1. No category

Vaccine
Storage& Handling
Toolkit
May 2014
U.S. Department of Health and Human Services
Centers for Disease Control and Prevention
Table of Contents
Tips for the Using the Toolkit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Vaccine Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Background. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Value of Vaccine Storage and Handling Best Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Vaccine Storage and Handling Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Manufacturer Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Avoiding Mistakes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Vaccine Cold Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
What is the Vaccine Cold Chain?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Importance of Maintaining the Vaccine Cold Chain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Vaccine Potency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Vaccine Appearance after Exposure to Inappropriate Storage Conditions . . . . . . . . . . . . . . . . 12
Consequences of Vaccine Cold Chain Failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Storage and Handling Plans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
General Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Routine Vaccine Storage and Handling Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Emergency Vaccine Retrieval and Storage Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Advance Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
What’s in an Emergency Plan?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Equipment failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Impending emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Power outages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
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Table of Contents
Staff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Primary Vaccine Coordinator and Alternate (Back-up) Vaccine Coordinator . . . . . . . . . . . . . . 24
Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Vaccine Storage Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
General Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Equipment Logbook. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Vaccine Storage Equipment Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Stand-alone Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Combination Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Dormitory-style Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Storage Unit Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Required Temperature Ranges for Storage Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Refrigerators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Freezers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Setting and Stabilizing Temperatures in Storage Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Thermostats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Adjusting Storage Unit Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Stabilizing Temperatures with Water Bottles and Frozen Coolant Packs . . . . . . . . . . . . . 33
Doors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Deli, fruit, and vegetable drawers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Storage Unit Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Routine Maintenance Tasks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Back-up Generators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Temperature Monitoring Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Temperature Monitoring Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
General Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
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Table of Contents
Calibrated Temperature Monitoring Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Types of Temperature Monitoring Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Continuous monitoring devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Digital data loggers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Temperature Monitoring Devices that are NOT Recommended . . . . . . . . . . . . . . . . . . . . 42
Temperature Monitoring Device Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Vaccine Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Protecting Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Temperature Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Vaccine Storage and Handling Best Practices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Vaccine and Diluent Storage Temperatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Freezer Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Refrigerator Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Diluents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Vaccine and Diluent Placement within Storage Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Freezers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Refrigerators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Spacing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Trays and Containers/Bins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Storage of Non-Vaccine Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Food and Beverages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Other Medications and Biologic Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
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Storage Unit Temperature Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Reviewing and Recording Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Reviewing Temperature Recording Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Noting Equipment Failures and Room Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Handling Inappropriate Vaccine Storage Conditions (Light and Temperature) . . . . . . . . . . . . 55
Handling Malfunctioning Vaccine Storage Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
General Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Temperature Monitoring Device Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Temperature Monitoring Device Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Checking if Device Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Checking Repeated Alarm Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Vaccine Inventory Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Vaccine Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Expiration Dates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Interpreting Expiration Dates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Exceptions to Expiration Dates on Labels (Beyond Use Date) . . . . . . . . . . . . . . . . . . . . . . . 60
Vaccines and Diluents that Cannot Be Used Before Expiration. . . . . . . . . . . . . . . . . . . . . . 61
What to Do with Expired and Mishandled Vaccines and Diluents . . . . . . . . . . . . . . . . . . . 61
Stock Rotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Vaccine Inventory Accounting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
General Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Vaccine Stock Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Tally Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Documenting Administered, Wasted, Compromised, Expired, and
Transferred Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
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Counting Stock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Vaccine Stock Calculations and Ordering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Vaccine Deliveries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Standard Operating Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Receiving and Unpacking Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Receiving Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Unpacking Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Storing and Documenting Deliveries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Vaccine Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Emergency or Off-site/Satellite Facility Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
General Recommendations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
General Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Vaccine Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Preparation for Vaccine Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Single-dose Vials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Multidose Vials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Manufacturer-filled Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Reconstitution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Lyophilized (Freeze-dried) Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Diluents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Predrawing Vaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Problems associated with this practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Influenza Clinics and Predrawing Vaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
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Vaccine Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Handle with Care Poster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Routine Vaccine Storage and Handling Plan Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
CDC’s Temperature Excursion Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Fahrenheit to Celsius and Celsius to Fahrenheit Conversion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
Sample Stock Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Stock Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Sample Tally Sheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Tally Sheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Warning Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Shipping Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Emergency Vaccine Retrieval and Storage Plan Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Emergency Management Internet Resources. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Manufacturer/Distributor Contact Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
7
Tips for the Using the Toolkit
Throughout the toolkit, icons will be used to alert the reader to requirements, recommendations,
best practices, scenarios that require immediate action, and hyperlink information.
Icon
Description
Contact your immunization program
if you are a Vaccines
for Children (VFC) provider or have other vaccines purchased
with public funds to ensure your storage and handling practices
meet state and federal requirements.
CDC Recommendation that applies to anyone who stores
vaccines
Best Practice
Take immediate action!
Link to more information about key messages
Link to content outside the Toolkit
Print warning! Printing this toolkit may not enable provider to have the most current information.
Refer to online version for the most current information.
Where to go for updated CDC information including webinars and other educational offerings
• Additional information is available on CDC’s Vaccine Storage and Handling webpage,
http://www.cdc.gov/vaccines/recs/storage/default.htm
. There is a place on this page
where you can sign up for notifications about updates to this page.
• Educational programs related to Vaccine Storage and Handling, e.g., webinars or netconferences,
can be accessed at http://www.cdc.gov/vaccines/ed/default.htm
.
Where to get questions answered
• If you have questions, contact your state/local immunization program,
http://www.cdc.gov/vaccines/imz-managers/awardee-imz-websites.html
• You can also send questions to CDC at [email protected]
8
Introduction
Key Messages:
This toolkit provides vaccine storage and handling best practices.
CDC encourages providers to move toward implementing these recommendations as soon
as possible.
Refer to the manufacturer’s product information/package inserts
handling guidance for individual vaccines.
for storage and
VFC providers or providers who have other vaccines purchased with public funds should
consult their immunization program
for specific recommendations and requirements.
Vaccine Storage and Handling
Background
The Centers for Disease Control and Prevention (CDC)
Vaccine Storage and Handling Toolkit provides best
practices based on recommendations of the Advisory
Committee on Immunization Practices (ACIP), vaccine
manufacturers’ product information, and studies
conducted by the National Institute of Standards and
Technology (NIST). CDC encourages immunization
providers to move toward implementing these best
practices and recommendations as soon as possible.
or handled improperly). Storage and
handling errors can also result in
significant financial loss if the vaccine(s)
cannot be used.
Vaccine Storage and Handling
Protocols
State/local health department
immunization programs (herein referred
to as “immunization program[s]”)
throughout the United States have been
successful in preventing and eradicating
vaccine-preventable diseases in part
If you are a Vaccines for Children (VFC) provider or
because of proper storage and handling
if you have other vaccines purchased with public funds,
practices. Immunization programs and
you should consult your immunization program
for
practices should have written protocols
recommendations and requirements specific to your area. for routine vaccine storage and handling,
as well as for emergency procedures. This
Value of Vaccine Storage and Handling Best
toolkit provides guidance for developing
Practices
and updating those protocols. Storage
Failure to store and handle vaccines properly can reduce and Handling Plans that include stepvaccine potency, resulting in inadequate immune
by-step protocols should be easily
responses in patients and poor protection against
accessible in every facility that provides
disease. Patients lose confidence in vaccines and their
immunizations.
providers when revaccination is necessary because the
vaccine(s) they received may have been compromised
(exposed to inappropriate conditions/temperatures
9
Introduction
Manufacturer Protocols
Refer to the manufacturer’s product information and package inserts
storage and handling protocols for individual vaccines.
for specific, detailed
Avoiding Mistakes
Adherence to best practices and guidance in this toolkit can assist providers in avoiding storage and
handling mistakes that can be very costly.
Notes:
10
Vaccine Cold Chain
Key Messages:
The vaccine cold chain is a temperature-controlled
environment used to maintain and distribute
vaccines in optimal condition.
Cold Chain Flow Chart
Manufacturer
Responsibility
Vaccine
Manufacturer
Monitor the temperature of your storage unit(s)
regularly to assure that appropriate conditions are
maintained.
Take immediate corrective action when a storage
unit temperature is outside the recommended range
(Troubleshooting).
Call the vaccine manufacturer for guidance.
If you are a VFC provider or have other vaccines
purchased with public funds, contact your
immunization program
.
Vaccine appearance is NOT a reliable indicator
that vaccines have been stored under appropriate
conditions.
Vaccine exposed to inappropriate temperatures that
is inadvertently administered generally should be
repeated. Contact your immunization program
,
vaccine manufacturer(s), or both for guidance.
Manufacturer/Distributor
Responsibility
Provider
Responsibility
Vaccine
Distribution
Vaccine Arrival
at Provider
Facility
Vaccine
Storage
and Handling
at Provider
Facility
Vaccine
Administration
What is the Vaccine Cold Chain?
The vaccine cold chain is a temperature-controlled environment used to maintain and distribute
vaccines in optimal condition. The cold chain relies on three main elements:
• Well-trained personnel
• Reliable transportation and storage equipment
• Efficient management procedures
The cold chain begins with the cold storage unit at the manufacturing plant, extends through
transport of vaccine(s) to the distributor, then delivery and storage at the provider facility, and ends
with administration of vaccine to the patient. Appropriate storage conditions must be maintained at
every link in the cold chain.
11
Vaccine Cold Chain
Importance of Maintaining the Vaccine Cold Chain
Vaccine Potency
Excessive heat, cold,
or light exposure can
damage vaccines,
resulting in reduced
potency. Once potency
is lost, it cannot be
restored. Each time
vaccines are exposed
to improper conditions,
potency is reduced
further. Eventually, if the
cold chain is not properly
maintained, potency will
be lost, and the vaccines become useless.
Vaccine Appearance after Exposure to
Inappropriate Storage Conditions
Some vaccines may
show physical evidence
that potency has been
reduced when exposed
to inappropriate storage
conditions. This may appear as
clumping in the solution that
does not go away when the
VACCINE
vial is shaken. Other vaccines
may look normal when
exposed to inappropriate
storage conditions (see
photos below). For example, inactivated vaccines
exposed to freezing temperatures (i.e., 32°F [0°C]
While exposure to any inappropriate conditions
or colder) may not appear frozen and give no
can affect potency of refrigerated vaccines, a
indication of reduced or lost potency. Vaccine
single exposure to freezing temperatures will
appearance is NOT a reliable indicator that
destroy some. Liquid vaccines that contain an
vaccines have been stored under appropriate
aluminum adjuvant* can permanently lose
conditions.
potency when exposed to freezing temperatures.
Monitor the temperature of your storage unit(s)
regularly.
Take immediate corrective action when a
storage unit temperature reading is outside the
recommended range (temperature excursion).
Call your immunization program
and/
or the vaccine manufacturer for guidance
(Troubleshooting).
If you are a VFC provider or have other
vaccines purchased with public funds, contact
your immunization program
.
Can you spot
the difference?
Properly stored
vaccine
Full Potency
Improperly stored
vaccine
Diminished Potency
Vaccine appearance is NOT a reliable indicator that vaccines
have been stored under appropriate conditions.
*Adacel, Boostrix, Cervarix, Comvax, Daptacel, Decavac, Engerix-B, Gardasil, Havrix, Infanrix, Kinrix, Pediarix, PedvaxHIB,
Pentacel, Prevnar 13, Recombivax HB, Tenivac, Twinrix, and Vaqta contain an aluminum adjuvant, which boosts the immune
response to the vaccine.
12
Vaccine Cold Chain
Store in Refrigerator
Between 35°F and 46°F (2°C and 8°C)
MMR†§
HepA
HepB
Hib†
Hib-HepB
HepA-HepB
Human papillomavirus (HPV2 and HPV4†)
Influenza (LAIV, IIV,† RIV†)
Store in Freezer
Between -58°F and +5°F (-50°C and -15°C)
IPV†
Meningococcal-containing
(Hib-MenCY,† MCV4,† MPSV4)
VAR†
Pneumococcal (PCV13 and PPSV23)
HZV†
Rotavirus† (RV1 and RV5)
MMRV†
Diphtheria toxoid-, Tetanus toxoid-,
MMR†§
and Pertussis-containing
(DT, DTaP, DTaP-HepB-IPV, DTaP-IPV,
DTaP-IPV/Hib, Tdap, Td, TT)
†Protect the following vaccines from light: Varivax, Zostavax, ProQuad, M-M-R II, Hiberix, Gardasil, Afluria,
Agriflu, Fluarix, Flublok, Flucelvax, FluLaval, Fluvirin, IPOL, MenHibrix, Menveo, Rotarix, and RotaTeq.
§Unreconstituted lyophilized (freeze-dried) MMR may be frozen or refrigerated.
13
Vaccine Cold Chain
Consequences of Vaccine Cold Chain Failure
Reduced vaccine potency due to inappropriate storage conditions can be costly.1,2,3 Patients who
receive vaccine with reduced potency caused by inappropriate storage conditions may not be fully
protected against vaccine-preventable diseases.
In General Recommendations on Immunization, ACIP recommends “vaccine exposed to
inappropriate temperatures that is inadvertently administered generally should be repeated.”4
Contact your immunization program
, vaccine manufacturer(s), or both for guidance about
recalling patients for revaccination. Vaccine recalls due to inappropriate storage can mean extra
doses for patients, increased costs for providers, and damage to public confidence in vaccines.
They also can be a liability for a provider’s practice. Patients who refuse revaccination can remain
unprotected from serious, vaccine-preventable diseases.
Vaccine inventories are very expensive. The costs associated with loss and replacement vaccines, and
resources necessary to conduct a recall of patients, can be significant. 5
References
1. Department of Health and Human Services, Office of Inspector General. Vaccines for Children
Program: Vulnerabilities in Vaccine Management, June 2012,
http://oig.hhs.gov/oei/reports/oei-04-10-00430.asp.
2. Gazmararian JA, Oster NV, Green DC, Schuessler L, Howell K, et al. Vaccine storage practices in
primary care physician offices: assessment and intervention. Am J Prev Med 2002;23(4):246–53.
3. Bell KN, Hogue CJR, Manning C, Kendal AP. Risk factors for improper vaccine storage and
handling in private provider offices. Pediatrics 2001;107(6):1–5.
4. Centers for Disease Control and Prevention. General Recommendations on Immunization:
Recommendations of the Advisory Committee on Immunization Practices and the American
Academy of Family Physicians. MMWR 2011;60 (No. RR-2):17–19. Available from URL:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm
5. Centers for Disease Control and Prevention. CDC vaccine price list. Atlanta, GA: CDC. Available from
URL:
http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/
14
Vaccine Cold Chain
Notes:
15
Storage and Handling Plans
Key Messages:
Develop and stick to a Routine Vaccine Storage and Handling Plan and update annually.
Develop an Emergency Vaccine Retrieval and Storage Plan and update annually.
If you are a VFC provider or have other vaccines purchased with public funds, contact your
immunization program
for guidance regarding routine and emergency plans.
Keep plans near storage unit(s) and make sure staff members know where to find them and
are familiar with their contents.
Ensure that custodial and security staff are aware of the emergency plan and know how to
notify appropriate staff if there is a problem.
If power is lost short-term (usually 2 hours or less), depending on room temperature, and if
there are water bottles in the refrigerator and frozen coolant packs in the freezer, storage
temperatures can probably be maintained if doors are kept closed.
Do NOT allow vaccines to remain in a nonfunctioning unit for an extended period of time.
Activate the emergency plan.
Check vaccine temperatures upon arrival at the alternate storage facility and ensure
immediate storage at manufacturer-recommended temperatures.
Consult your agency or immunization program
for any special emergency instructions.
General Recommendations
Develop and stick to a detailed written Routine Vaccine Storage and Handling Plan that is
updated annually. In this plan, include all aspects of routine vaccine management, from ordering and
managing inventory to monitoring storage conditions. A well-written plan will help providers stay
organized, serve as a reference and training tool, and provide quality assurance of proper vaccine
management (Routine Vaccine Storage and Handling Plan Worksheet).
In addition, develop a detailed written Emergency Vaccine Retrieval and Storage Plan in
the event of refrigerator and/or freezer malfunctions, power failures, natural disasters, or other
emergencies that might compromise appropriate storage conditions. Review and update the
emergency plan annually (Emergency Vaccine Retrieval and Storage Plan Worksheet).
Include signature, name, and title of the person(s) who prepared the plans.
Ensure that all staff members who administer or handle vaccines in any way are familiar with
these plans. Keep plans near storage unit(s) and make sure staff members know where to find them.
16
Storage and Handling Plans
Many components of routine and emergency
plans will be the same for every facility, but some
details may vary depending on local policies.
If you are a VFC provider or have other
vaccines purchased with public funds, contact
your immunization program
for guidance
regarding routine and emergency plans.
Each facility should have routine and emergency plans.
Routine Vaccine Storage and Handling
Plan
The information below is provided as a guideline
for developing your routine plan. You may also
use the Routine Vaccine Storage and Handling
Plan Worksheet.
Each routine plan should include:
• Up-to-date contact information for the
following:
––Persons who are responsible for routine
vaccine storage and handling, e.g.,
primary and alternate (back-up) vaccine
coordinators (Staff)
––Immunization Program
––Vaccine Manufacturers
––Refrigerator and freezer maintenance
and repair company(ies)
––Utility/power company
––Vaccine storage unit alarm company (if
applicable)
––Sources of qualified containers, packing
materials, and calibrated temperature
monitoring devices
• Descriptions of roles and responsibilities
of primary and alternate (back-up) vaccine
coordinators (Staff).
• Policy on education and training for facility
staff.
• Protocols for:
––Ordering and accepting vaccine
deliveries (Vaccine Stock Calculations
and Ordering and Receiving and
Unpacking Deliveries)
––Storage unit temperature monitoring
––Storage equipment maintenance
––Correct placement of vaccines within
storage units (Vaccine and Diluent
Placement within Storage Unit)
––Responding to storage and handling
problems (Troubleshooting)
––Inventory management (contact
your immunization program
for
details and see Vaccine Inventory
Management for general guidelines)
––Receiving and unpacking deliveries
(contact your immunization program
for details and see Vaccine
Deliveries)
––Transporting vaccines in an emergency
or to off-site/satellite facilities (contact
your immunization program
for
details and see Vaccine Transport for
general guidelines)
––Handling vaccines prior to
administration (Vaccine Preparation)
––Proper disposal of vaccines and supplies
(contact your immunization program
17
Storage and Handling Plans
•
•
•
•
for details and see Vaccine Disposal
for general guidelines)
Storage requirements for each vaccine and
diluent in your inventory (package inserts).
Samples of forms used in your facility (e.g.,
ordering forms, temperature logs, stock
records, etc.).
Additional resources are available in
Resources and from the Immunization
Action Coalition (IAC): Clinic Resources –
Storage and Handling.
Also establish a checklist of procedures and
post it on all vaccine storage unit(s) (IAC’s
Checklist for Safe Vaccine Storage and
Handling).
Emergency Vaccine Retrieval and
Storage Plan
Advance Preparations
Various situations may compromise vaccine
storage conditions, such as equipment failures,
power outages, or natural disasters. Ensure
that the emergency plan includes up-to-date
information regarding procedures to follow
to protect and/or retrieve vaccines as quickly
as possible when a potentially compromising
situation occurs. In addition to facility staff,
ensure that custodial and security staff are
aware of the emergency plan and know
procedures to follow to notify designated
staff about any problems with vaccine storage
equipment or power outages.
IAC’s Emergency Response Worksheet
to help organize your response. Consult your
agency or immunization program
for any
special instructions or forms.
Each emergency plan should include:
––Role of vaccine coordinator and alternate
(back-up)
––Emergency contact list
––Storage unit specifications
––Alternate storage facilities
––Written instructions for after hours
––Adequate supplies for packing and
transport
––Protocol for packing
––Protocol for transport
• Designated primary and alternate (backup) vaccine coordinators with emergency
contact information.
In addition to routine vaccine storage
and handling duties (Staff), primary and
alternate (back-up) vaccine coordinators
should:
––Monitor operation of storage equipment
and systems
––Track inclement weather conditions
––Set up and maintain monitoring/
What’s in an Emergency Plan?
The information below is provided as a
guideline for developing an emergency plan.
You may also use the Emergency Vaccine
Retrieval and Storage Plan Worksheet and
Staff members should be familiar with the Routine and
Emergency Vaccine Storage and Handling Plan.
18
Storage and Handling Plans
notification system during times of
inclement weather or other conditions
that might cause a power outage (a
continuous-monitoring temperature
alarm/notification system should be
considered, especially for facilities with
large inventories)
––Post emergency contact information on
circuit breaker(s) or electrical panel
––Ensure appropriate handling of vaccine
during a disaster or power outage
––Ensure 24-hour access to building and
vaccine storage unit(s)
––Ensure that sufficient fuel is on hand
to continuously run generator for at
least 72 hours if facility has a back-up
generator
• Emergency staff contact list in order of
contact preference.
Determine whether all or certain persons on
the list should be contacted in the event of
a vaccine storage emergency or if the first
person reached is sufficient. Include primary
and alternate (back-up) vaccine coordinators
on the list. Record names (in order) and
contact information. Assure that contact
information is updated at least quarterly.
• Vaccine storage unit specifications.
For each vaccine storage unit in your facility,
identify type of unit (e.g., stand-alone
refrigerator), brand name, model number,
and serial number. These specifications may
be useful for the repair company.
• Alternate vaccine storage facility or facilities.
Establish working agreements with at
least one alternate storage facility with a
back-up generator where vaccines can be
appropriately stored and monitored for the
interim (e.g., hospital, long-term care facility,
state depot, Red Cross, fire station, packing
plant, commercial pharmacy). Make advance
arrangements with facility(ies) to store your
vaccines when weather predictions call
for inclement conditions (e.g., tornadoes,
hurricanes, ice, severe snowstorms), when
your storage equipment cannot be repaired,
or when power cannot be restored before
the storage unit temperature rises above
the recommended range. Record name
of alternate facility(ies), name of contact
Establish at least one alternate storage facility where vaccine can be appropriately stored and monitored.
This facility should have a back-up generator.
19
Storage and Handling Plans
person(s), and telephone number(s). Include
instructions for 24-hour access.
• Written instructions for entering your facility
and vaccine storage spaces in an emergency
if building is closed. In these instructions,
include the building security/after-hours
access procedure, floor diagram, and
locations of the following:
––Alarms (including instructions for use)
––Doors
––Flashlights
––Spare batteries
––Light switches
––Keys
––Locks
––Circuit breakers
––Packing materials
• Adequate supply of qualified containers
and packing materials for facility’s largest
annual inventory. Appropriate materials
may include portable actively or passively
cooled refrigerator/freezer units, hard-sided
insulated containers, “conditioned” coolant
packs that are cold or frozen (depending
on type of vaccine), and a calibrated
temperature monitoring device for each
container (Vaccine Transport). In situations
where an alternate vaccine storage facility
with a back-up generator cannot be
identified within a reasonable distance,
qualified containers and packing materials
can be used to store vaccines temporarily
and safely at your facility. This temporary
storage should only be for as long as the
container and pack out are qualified to
maintain storage temperatures and the
container remains closed. A temperature
monitoring device should always be placed
with the vaccines. Record names and contact
information for sources of materials.
• Written protocol for vaccine packing.
Develop standard operating procedures
(SOPs) for packing vaccines. Make
instructions readily available for staff. Key
steps that should be reflected in all SOPs are:
––Open refrigerator and freezer doors only
when absolutely necessary and only
after you have made all preparations
for packing and moving vaccines to an
alternate storage facility.
––Use qualified containers and packing
materials and procedures for refrigerated
and frozen vaccines (Vaccine Transport
for general guidelines).
• Written protocols, vehicles, and drivers for
transporting vaccines to and from alternate
vaccine storage facility.
––Vaccines may be transported within
non-commercial vehicles inside the
passenger compartment (not in trunk
because temperatures cannot be
controlled inside trunk). Make advance
arrangements for primary and backup vehicles and drivers and record the
contact information.
––If location is far away or if you have a
large quantity of vaccines, consider
renting a refrigerated truck. In this case,
joining with other facilities to reduce
costs may be advantageous. Make
advance arrangements with a local
refrigeration company and an alternate
and record contact information.
––Check with your immunization
program
for guidance and resources
on emergency transport of vaccines.
––Develop written protocols for
transporting vaccines to and from
alternate storage facility:
• Establish how to load vehicle.
20
Storage and Handling Plans
• Have pre-selected routes to take (and
alternate routes if necessary).
• Determine estimated time en route.
Improper packing of vaccines for transport
is as risky as storage unit failure. Vaccine
manufacturers do not support reuse of their
containers and packing materials for vaccine
transport. Improper repackaging using these
materials and improper transportation could
negatively impact vaccines.
Emergency Procedures
Equipment failure
No piece of vaccine storage equipment is
infallible, and there is always potential for vaccine
storage equipment failure. At some point,
equipment failure will occur related to a power
failure, breakdown, or normal wear and tear. Part
of a provider’s responsibility for proper vaccine
storage is preparing for equipment failure by
having back-up equipment and back-up plans
available.
Impending emergency
When state officials, local officials, or providers
have reasonable cause to believe that
weather conditions, natural disasters, or other
emergencies might disrupt power in or flood any
facility where vaccines are stored, implement
emergency procedures in advance of event.
Power outages
If power is lost short-term (usually 2 hours or less)
and depending on room temperature, storage
temperatures can probably be maintained with
water bottles in the refrigerator, frozen coolant
packs in the freezer, and by taking the following
steps:
• Do not open storage unit door until power is
restored.
• Continue to monitor temperature inside
each storage unit.
––Some temperature monitoring devices
allow temperature monitoring without
opening storage unit door. In this
case, record room temperature and
temperature(s) inside unit(s) at time
problem is discovered, as well as
minimum and maximum temperature(s)
reached inside unit(s) during power
outage.
––If this type of temperature monitoring
device is not being used, do not open a
storage unit door to check temperature
during power outage. Document room
temperature and temperature inside
each storage unit as soon as possible
after power has been restored. If you
have a digital data logger, document
length of time power has been off and
minimum and maximum temperatures
observed within storage unit(s).
• When power is restored, if temperature
inside refrigerator is not between 35°F
and 46°F (2°C and 8°C) or if temperature
inside freezer is not between -58°F and
+5°F (-50°C and -15°C), document duration
of inappropriate temperature exposure
and follow procedures for Handling
Inappropriate Vaccine Storage Conditions
(Light and Temperature).
Do NOT allow vaccines to remain in a
nonfunctioning unit for an extended period
of time. If at any time you are unsure how
long the power interruption will last, or you
determine that power will not be restored in
time to maintain internal temperatures within
recommended ranges, activate your emergency
21
Storage and Handling Plans
plan.
• Suspend vaccination activities before onset
of emergency conditions, if possible.
This will allow sufficient time for packing
and transporting vaccines.
• Notify staff at alternate vaccine storage
facility.
Before moving your vaccines, contact
alternate storage facility to make them
aware of the situation and to ensure that
their back-up generator is working.
• Conduct an inventory of vaccines and record
actions taken.
Use the Emergency Vaccine Retrieval and
Storage Plan Worksheet. Also note if frozen
coolant packs were in freezer and water
bottles were in refrigerator at time of event.
• Pack the affected vaccines (Vaccine
Transport).
• Follow established vaccine transport
procedures (Written Protocols, Vehicles,
and Drivers for Transporting Vaccines
to and from Alternate Vaccine Storage
Facility).
• Check vaccine temperature upon arrival
at alternate storage facility and ensure
immediate storage at manufacturerrecommended temperatures.
electrical power failure or flood conditions
(Impact of Severe Weather Conditions on
Biological Products) .
If you have no warning and an emergency event
is already occurring or has already occurred,
you should still follow these procedures if
they can be done safely. Consult your agency
or immunization program
for special
instructions.
The Center for Biologics Evaluation and Research
(CBER) at the Food and Drug Administration
(FDA) offers general guidance concerning storage
and use of temperature-sensitive biological
products that have been involved in a temporary
22
Storage and Handling Plans
Notes:
23
Staff
Key Messages:
Designate one staff member to be the primary coordinator.
Designate at least one alternate (back-up) coordinator.
Primary and alternate (back-up) coordinators should be fully trained in routine and
emergency policies and procedures.
It is also important that a physician partner or member of management is directly involved
with responsible clinical staff—someone with a clear understanding of vaccine replacement
costs and clinical implications of mismanaged storage units and vaccines.
All staff who receive deliveries and handle or administer vaccines should be familiar with
storage and handling policies and procedures.
Storage and handling training should:
–– Be part of new employee orientation
–– Be annual training for all staff involved in these activities
–– Occur whenever recommendations are updated and when new vaccines are added
Click here for CDC’s online training module, You Call the Shots: Vaccine Storage and
Handling
.
Primary Vaccine Coordinator and Alternate
(Back-up) Vaccine Coordinator
Designate one staff member to be the
primary coordinator. This person will be
responsible for ensuring that all vaccines are
stored and handled correctly. Coordinator
responsibilities include but are not limited to:
• Ordering vaccines
• Overseeing proper receipt and storage of
deliveries
• Organizing vaccines within storage unit(s)
• Reading and recording storage unit
temperatures a minimum of 2 times each
workday
• Reading and recording minimum/maximum
temperatures once per workday, preferably 1
time each morning
• Downloading and reviewing temperature
data at least 1 time each week
• Making sure the door is firmly closed when
not in use
• Rotating stock at least 1 time each week so
that vaccine closest to the expiration date
will be used first
• Removing expired vaccine from storage
unit(s) so that it is not used
• Responding to possible temperature
excursions (Handling Inappropriate
Vaccine Storage Conditions [Light and
Temperature])
• Overseeing proper Vaccine Transport
• Maintaining all documentation, including
temperature excursion responses and VFC
program records
• Ensuring adequately trained staff
24
Staff
Also designate at least one alternate
(back-up) coordinator who will assume these
responsibilities in the absence of the primary
coordinator. Coordinators should be fully
trained in routine and emergency policies and
procedures. It is also important that a physician
partner or member of management is directly
involved with responsible clinical staff—
someone with a clear understanding of vaccine
replacement costs and clinical implications of
mismanaged storage units and vaccines.
Designate a Primary Vaccine Coordinator and at least one
Alternate (back-up) Vaccine Coordinator.
Training
If you are a VFC provider or have other
vaccines purchased with public funds, contact
your immunization program
regarding
required training and resources.
All staff who receive deliveries and handle
or administer vaccines should be familiar with
storage and handling policies and procedures at
their facility. This includes anyone who accepts
vaccine deliveries or who may have access to
unit(s) where vaccines are stored. Include storage
and handling training as part of new employee
orientation and provide annual training for all
staff involved in storage and handling activities.
To maintain staff competency, provide training
whenever recommendations are updated and
when new vaccines are added to inventory.
Record dates of trainings and names of
participants. Skill checks are also recommended
to validate competence (IAC’s Checklist for Safe
Vaccine Storage and Handling)
.
Click here for CDC’s online training module, You
Call the Shots: Vaccine Storage and Handling
. This toolkit can also serve as a reference
guide in conjunction with other resources on the
CDC Storage and Handling web page.
Many
immunization programs
and professional
organizations also offer vaccine storage and
handling training programs.
25
Staff
Notes:
26
Vaccine Storage Equipment
Key Messages:
Keep a logbook for each piece of storage equipment.
CDC recommends stand-alone units or pharmacy grade/purpose-built units.
CDC does not recommend and VFC does not allow storage of any vaccine in a dormitorystyle (or bar-style) refrigerator under any circumstances.
When setting up a storage unit, allow at least 4 inches (10 cm) of space between unit and wall.
Nothing should block the cover of unit motor compartment.
Make sure that unit stands firm and level and is 1 to 2 inches (2.5 to 5 cm) above the floor.
Set refrigerator temperature mid-range to achieve an average of about 40°F (5°C).
The freezer should maintain temperatures between -58°F and +5°F (-50°C and -15°C).
Only primary or alternate (back-up) coordinator should adjust temperature of a vaccine storage unit.
Before using a new storage unit, allow for 1 week of temperature readings a minimum of 2
times each workday, including minimum/maximum temperatures 1 time each morning.
Water bottles can help maintain stable temperatures and serve as a physical barrier to
placing vaccines in an area where there is greater risk for temperature excursions (for
example, top shelf, floor, and in door racks of refrigerator).
Frozen coolant packs can help maintain stable temperatures and serve as a physical barrier when
placed along walls, back, and bottom of freezer, and inside racks of freezer door.
Routinely check unit door throughout the day and at end of workday to ensure it is tightly
closed. An open door alarm and self-closing door may prevent a problem. Check door seals
for sign of wear and tear.
Back-up generators should:
–– Be tested quarterly
–– Receive maintenance at least annually
–– Have sufficient capacity to run continuously for 72 hours
–– Have adequate fuel supply on hand
27
Vaccine Storage Equipment
Disclaimer: This chapter provides guidance on vaccine storage equipment, equipment maintenance, and
methods and devices used to protect vaccines against equipment failure. Use of trade names and commercial
sources in this toolkit is for identification only, and does not imply endorsement by the U.S. Department of
Health and Human Services (DHHS), the U.S. Public Health Service (PHS), or the Centers for Disease Control and
Prevention (CDC). Photographs from non-federal organizations are provided solely as a service to our users.
These photographs do not constitute an endorsement of these organizations by CDC or the federal government
and none should be inferred.
If you provide VFC vaccines or other vaccines purchased with public funds, contact your immunization
program
regarding requirements for vaccine storage equipment.
General Recommendations
Think of your storage equipment as an insurance policy to protect patients’ health and your facility
against costly vaccine replacement, inadvertent administration of compromised vaccine, and other
consequences (e.g., costs of revaccination and loss of patient confidence in your practice).
Equipment Logbook
Stand-alone Units
Keep a logbook for each piece of storage
equipment that includes the following:
• Serial number(s)
• Manuals, instructions, or links to equipment
websites
• Dates of installation
• Dates of routine maintenance
• Dates of repairs or servicing
• Name of company(ies) and contact
information
CDC recommends stand-alone
units that either refrigerate or freeze or
pharmaceutical/purpose-built units. These
units can vary in size, from compact, under-thecounter style to
large, stand-alone
units.
Refrigerator
Vaccines Between
Vaccine Storage Equipment
Recommendations
While CDC does not recommend
specific brands of storage units, CDC
does provide guidance on types
of storage units that offer greater
assurance of proper temperatures
based on equipment testing by
NIST
.
Refrigerators and freezers are available
in different grades (household,
commercial, and pharmaceutical) and
types (stand-alone, combination).
35°F and 46°F
Freezer
(2°C and 8°C)
Vaccines Between
-58°F and +5°F
(-50°C and -15°C)
Stand-alone freezer
Stand-alone refrigerator
28
Vaccine Storage Equipment
A NIST
study, conducted in 2009,
demonstrated that stand-alone or
pharmaceutical units maintain required
temperatures better than household/commercial
combination units, particularly the freezer
section of household, combination units.1
Minimum characteristics of refrigerators and
freezers used for vaccine storage include:
• Enough room to store the year’s largest
inventory a provider might have at busiest
point in the year without crowding (e.g., flu
season)
• Enough room to store water bottles in
refrigerator and frozen coolant packs in
freezer to stabilize temperatures (Stabilizing
Temperatures with Water Bottles and
Frozen Coolant Packs)
• Reliably maintains appropriate vaccine
storage temperatures year-round
It is normal for ice and frost to accumulate
inside the freezer (and even in some types of
refrigerators). A thin layer of frost does not
affect cooling performance, but a thick layer
will affect a unit’s ability to efficiently maintain
temperatures and will eventually cause failure.
If your stand-alone freezer is manual defrost,
defrost it regularly to maintain temperature
stability. You will need another storage unit that
maintains appropriate freezer temperatures for
temporary vaccine storage while defrosting. The
following is a suggested defrosting procedure:
1. Check inside walls of freezer weekly
a. When frost has accumulated to a
thickness of approximately 1 cm, unit
should be defrosted
b. The more the unit is opened/closed, the
quicker frost will accumulate
c. Follow manufacturer’s
recommendations for defrosting
2. Remove all vaccines
3. Place vaccines in alternate unit that
maintains appropriate temperatures
4. Turn off power and unplug unit being
defrosted
5. Remove frozen coolant packs and keep
frozen
6. Keep freezer door open and allow ice to melt
7. Remove loose ice by hand, do NOT use a
sharp tool
8. Place container of warm (NOT boiling)
water in freezer to speed melting
9. Clean and dry unit when all ice is melted
10.Clean refrigerator compartment, if
combination unit
11.Connect to power and set thermostat to
correct setting
12.Monitor temperature with calibrated
thermometer every hour for several hours
until stable and within appropriate range.
May take days for some units
13.Restock with vaccines once temperature is
stable
14.Continue to monitor temperature closely
If defrosting is necessary every month or more
frequently, check door seals or call a technician
for necessary maintenance.
A frost-free unit with an automatic defrost cycle
may be preferred if regular manual defrosting
cannot be assured.
29
Vaccine Storage Equipment
Combination Units
Typical household single-condenser combination
refrigerator/freezer units are less capable of
simultaneously maintaining proper storage
temperatures in refrigerator and freezer
compartments. Most of these types of units have
cold spots and temperature fluctuations in the
refrigerator portion of the unit. Risk of freezedamage to refrigerated vaccines is increased
because air from the freezer is circulated for cooling
into the refrigerator. Freezer compartments in these
units have demonstrated that they are not capable
of maintaining correct temperatures for frozen
vaccines.
Purchasing new vaccine storage equipment may
require planning.
If existing equipment is
a household, combination refrigerator/freezer,
CDC recommends using only the refrigerator
compartment for refrigerated vaccines. Keep
the freezer compartment on to maintain proper
temperatures in the refrigerator. However, water
bottles should be added to the refrigerator to
reduce risk of freezing vaccines (Stabilizing
Temperatures with Water Bottles and Frozen
Coolant Packs). Use a stand-alone freezer for frozen
vaccines.
Because freezing refrigerated vaccines can affect
vaccine potency, it is especially important that
refrigerators be selected and set up in a way that
eliminates this risk (Refrigerators).
FREEZER
Refrigerated
Vaccines
ONLY
Combination refrigerator/freezer
Dormitory-style Units
CDC does not recommend storage of any vaccine
in a dormitory-style (or bar-style), combined
refrigerator/freezer unit under any circumstances.
A dormitory-style refrigerator is defined as a
combination refrigerator/freezer unit that is
outfitted with one exterior door and an evaporator
plate (cooling coil), which is usually located inside
Water bottles in refrigerator to absorb cold air blown in from
freezer to reduce risk of vaccines becoming too cold
30
Vaccine Storage Equipment
an icemaker compartment (freezer) within the
refrigerator. In performance testing, this type of
unit demonstrated consistently unacceptable
performance, regardless of where vaccines were
placed. It also exhibited the inability to maintain
temperatures and there were wide variations
throughout the unit. There is no “good” vaccine
storage area in this style unit.1 These units pose
a significant risk of freezing vaccine even when
used for temporary storage.
Use of dormitory-style units for storage of VFC
vaccines or other vaccines purchased with public
funds is prohibited. Note, size is not always an
indicator of this type unit. There are compact,
purpose-built storage units for biologics that are
not considered to be dormitory-style or bar-style
and can be used for vaccine storage.
legs are adjusted so the bottom of the unit is 1
to 2 inches (2.5 to 5 cm) above the floor. Refer to
the manufacturer-supplied owner’s manual for
additional guidance on placement.
Required Temperature Ranges for Storage
Units
Refrigerators
The refrigerator should maintain temperatures
between 35°F and 46°F (2°C and 8°C). Set the
temperature mid-range to achieve an average of
40°F (5°C). This temperature setting will provide
the best safety margin.
Freezers
The freezer should maintain temperatures
between -58°F and +5°F (-50°C and -15°C).
Setting and Stabilizing Temperatures in
Storage Units
Thermostats
Dormitory-style (or bar-style) combined refrigerator/freezer
units should NOT be used for any storage of any vaccine.
Storage Unit Placement
Good air circulation around the storage unit is
essential. Place the unit(s) in a well-ventilated
room with space around the sides and top. Allow
at least 4 inches (10 cm) of space between unit
and wall. Nothing should block the cover of the
motor compartment, which is normally located
at the back or side of the unit. Make sure the
unit stands firm and level and wheels or leveling
Consult the owner’s manual for instructions on
how to operate the thermostat. Refrigerator and
freezer thermostats are marked in various ways,
depending on brand, to indicate the temperature
setting. For example, some have a series of
numbers or letters on the control knob. Others
have “MIN,” “MED,” and “MAX” marked on the
knob or a dial ranging from “cold” to “coldest.” In
general, thermostats do not show temperatures,
but rather levels of coldness. The only way to
know what the temperature is where vaccines
are stored is to measure and monitor it with a
calibrated thermometer.
Adjusting Storage Unit Temperatures
Only primary or alternate (back-up) coordinators
should adjust the temperature of a vaccine
31
Vaccine Storage Equipment
storage unit. Post a
warning sign on storage
unit(s) that says, “Do
NOT adjust refrigerator
(or freezer) temperature
controls. Notify (insert
name) if adjustments
are necessary.” In
Refrigerator unit thermostat
some situations, the
thermostat may need to
be reset in summer and winter, depending
on room temperature.
Freezer unit thermostat
Use caution in adjusting a thermostat. It should
not be done during a busy clinic day when there is
frequent door opening and closing.
• First, be sure unit is plugged into power
source.
• Then check temperature inside storage unit.
• Next, check thermometer data from
continuous data loggers (if applicable) to
verify that temperature control reset is
appropriate.
To adjust the control and avoid exceeding the
required temperature range:
Only primary or alternate (back-up) vaccine
coordinators should adjust the temperature
of a vaccine storage unit.
• Turn thermostat knob slowly, making small
adjustments toward a warmer or colder
setting as necessary.
• Allow temperature inside unit to stabilize for
30 minutes.
• Then recheck temperature.
• Adjust thermostat again as necessary. Aim to
stabilize refrigerator temperature around 40°F
(5°C). Aim to stabilize freezer temperature
between -58°F and +5°F (-50°C and -15°C).
• Recheck temperature every 30 minutes until
Only the primary or alternate (back-up) vaccine coordinator
stable.
should adjust the temperature of a vaccine storage unit.
––Consider placing additional water bottles
to increase temperature stability
32
Vaccine Storage Equipment
If you are using the refrigerator compartment of
a household, combination unit, use care when
adjusting the freezer temperature because this
will affect the temperature of air venting into
the refrigerator compartment. Without careful
and frequent temperature monitoring inside the
refrigerator compartment, there is risk of freezing
refrigerated vaccines.
It may take 2 to 7 days to stabilize the
temperature between 35°F and 46°F (2°C and
8°C) in a newly installed or repaired refrigerator.
Likewise, it may take 2 to 3 days to stabilize the
temperature between -58°F and +5°F (-50°C
and -15°C) in a newly installed or repaired
freezer. Allow a week of refrigerator and freezer
temperature readings/recordings a minimum
of 2 times each workday, including minimum/
maximum temperatures 1 time each morning
(Storage Unit Temperature Monitoring) to
make sure temperatures are within appropriate
ranges before using units to store vaccines.
Stabilizing Temperatures with Water Bottles and
Frozen Coolant Packs
Water bottles and frozen coolant packs will help
maintain stable temperatures with frequent
opening and closing of unit doors, in the event
of a power failure, and serve as a physical barrier
to placing vaccines in an area where there is
greater risk for temperature excursions. Place
water bottles on top shelf, floor, and in door
racks of refrigerator. The Joint Commission on
Accreditation of Healthcare Organizations (Joint
Commission) does not recommend storage of
food or beverages in a medication storage unit,
so label water bottles “Do NOT Drink.”
Place frozen coolant packs along walls, back,
and bottom of freezer, and inside door racks.
Place items in unit doors carefully so they cannot
dislodge, and prevent doors from closing or
weighing them down so much that seals are not
tight.
NEVER store vaccine in a unit that cannot
maintain the required temperature range. Identify
an alternate unit that is able to maintain the
appropriate temperature range and has sufficient
storage space until the primary unit is ready.
Stabilize temperature in a refrigerator with water bottles
labeled “Do NOT Drink.” Stabilize temperature in a freezer
with frozen coolant packs.
33
Vaccine Storage Equipment
Doors
Avoid letting the door stand open unnecessarily.
Not only does this affect temperature in the
unit, it also exposes vaccines to light, which can
reduce potency of some vaccines (see package
inserts
). Leaving the door open can cause
the temperature control to respond to warmer
air temperatures from the room. The unit will
then continue to work harder to maintain the
correct temperature inside the unit. The unit will
continue to adjust output of cool air and increase
the possibility that temperatures will become
very cold in some part of the unit. Routinely
check refrigerator and freezer doors throughout
the day and at the end of each workday to ensure
they are tightly closed. Use of an open door
alarm and self-closing doors may be helpful in
preventing a problem.
Also ensure door seals are tight each time the
door is closed and at the end of the workday.
Check regularly for signs of wear and tear. Seals
should not be torn or brittle and there should be
no gaps between seals and body of the unit when
the door is closed. The door should open and
close properly and fit squarely against body of the
unit. For this to happen, hinges must be correctly
adjusted. If there are any problems with a door
seal, see Assessing Storage Unit Door Seals. Call
a repair technician if seals need to be replaced.
Deli, fruit, and vegetable drawers
Remove any deli, fruit, and vegetable drawers
from the refrigerator. Removing drawers not only
provides extra space for storing containers of water,
but it also removes the temptation to use drawers
for storage of food, beverages, or vaccines.
Some pharmaceutical grade units have built-in
drawers. Testing demonstrated that these units
maintain good temperatures for vaccine storage.
However, maintaining appropriate vaccine
temperature relies on good
air circulation.
Storage Unit Maintenance
Regular maintenance is
required to ensure proper
operation, to maintain
required temperatures,
and to extend useful life
of the equipment. Check
manufacturer specifications
for cleaning instructions and
recommended maintenance
schedules. Document
routine maintenance tasks
and repairs (Equipment
Logbook).
Place water bottles on the top shelf,
floor, and in door racks of refrigerator.
Place frozen coolant packs along walls, back,
and bottom of freezer, and inside door racks.
34
Vaccine Storage Equipment
Routine Maintenance Tasks
Clean coils and motor.
Keep storage unit coils and motor free of dust and dirt build-up. Dust and dirt build-up affect
transfer of heat from coils and, therefore, efficiency of the unit. For safety reasons, you may need to
unplug your unit to do this, so check manufacturer instructions.
Clean inside refrigerator and freezer units.
This discourages bacterial and fungal growth. Cleaning should
be done quickly to minimize risk of the temperature going out of
range.
Clean drain pan.
Clean the drain pan periodically. Frost-free freezers have a drain
pan at the bottom of the unit. It holds water that collects after
frost melts during the defrost cycle. You do not need to empty
the pan regularly as the water should evaporate. However, over
time, it may begin to smell and become moldy so check and
clean as needed.
Refrigerator Coils
Back-up Generators
Facilities storing large vaccine inventories should consider installing
back-up generators that automatically provide power to storage units
in the event of power outages. Back-up generators should be tested
quarterly and should receive maintenance at least annually (check
manufacturer specifications for test procedures and maintenance
schedules).
Back-up Generators
References
1. Chojnacky MJ, Miller WW, Ripple DC, Strouse GF. Thermal Analysis of Refrigeration Systems
Used for Vaccine Storage. November 2, 2009. http://www.nist.gov/manuscript-publicationsearch.cfm?pub_id=904574
35
Vaccine Storage Equipment
Notes:
36
Temperature Monitoring Equipment
Key Messages:
CDC recommends and VFC requires using only calibrated temperature monitoring devices
with a Certificate of Traceability and Calibration Testing (also known as Report of Calibration).
Calibration testing should be performed every 1 to 2 years or according to manufacturer’s
suggested timeline. VFC providers should consult their immunization program
for
specific requirements.
If calibration testing indicates that your thermometer is no longer accurate within
+/-1°F (+/-.5°C), then your thermometer should be replaced.
CDC recommends and immunization program
thermometer.
may require having a back-up
CDC recommends using digital data loggers for continuous temperature monitoring.
Staff should be trained and understand how to set up, read, and analyze temperature data
provided by the data logger. Consult your immunization program
for data logger
selection and training resources.
The temperature monitoring device should be near where vaccines are stored.
Disclaimer: This chapter provides guidance on temperature monitoring equipment. Use of trade names and
commercial sources in this toolkit is for identification only, and does not imply endorsement by the U.S.
Department of Health and Human Services (DHHS), the U.S. Public Health Service (PHS), or the Centers for
Disease Control and Prevention (CDC). Photographs from non-federal organizations are provided solely as a
service to our users. These photographs do not constitute an endorsement of these organizations by CDC or the
federal government and none should be inferred.
If you provide VFC vaccines or other vaccines purchased with public funds, contact your immunization
program
regarding requirements for temperature monitoring equipment.
Temperature Monitoring Devices
Calibrated Temperature Monitoring Devices
General Recommendations
For measuring vaccine storage unit
temperatures, CDC recommends using only
calibrated temperature monitoring devices
with a Certificate of Traceability and Calibration
Testing (also known as Report of Calibration).
Calibration testing and traceability that is
performed by a laboratory with accreditation
from an International Laboratory Accreditation
Cooperation (ILAC) Mutual Recognition
Arrangement (MRA) signatory body assures
the user that testing performed meets the
appropriate standard. An alternative is a
Accurate temperature history that reflects actual
vaccine temperatures is imperative to effective
vaccine management. Investing in reliable
temperature monitoring devices is less expensive
than replacing vaccines wasted due to inaccurate
temperature readings.
37
Temperature Monitoring Equipment
laboratory or manufacturer that provides
documentation that demonstrates calibration
testing performed meets International
Organization for Standardization/International
Electrotechnical Commission (ISO/IEC) 17025
international standards for calibration testing and
traceability. If a temperature monitoring device
claims to be “certified,” this does not mean that it
has been tested to meet ISO/IEC 17025 standards.
CDC’s recommendation is that testing
be performed by ILAC accredited laboratories
because it is the easiest way to identify that
the instrument has been tested correctly
according to international standards. Providers
are responsible for maintaining up-to-date
certificates of calibration.
If calibration testing was performed by ILAC/
MRA accredited laboratories, certificates should
include the following elements:
1. Clearly identifiable accreditation
2. Name of device (optional)
3. Model number
4. Serial number
5. Date of calibration (report or issue date)
6. Measurement results that indicate passed
testing and documented uncertainty
within suitable limits (recommended
uncertainty is +/-1 F [+/-.5 C])
Non-ILAC accredited laboratories and
manufacturers must provide a Certificate of
Traceability (Report of Calibration) that includes
the following elements:
1. Name of device (optional)
2.
3.
4.
5.
Model number
Serial number
Date of calibration (report or issue date)
Measurement results that indicate passed
testing and documented uncertainty
within suitable limits (recommended
uncertainty is +/-1 F [+/-.5 C])
6. Measurement results for the device
7. Statement that calibration testing
conforms to ISO 17025
Follow links for listings of accredited laboratories:
The American Association for Laboratory
Accreditation (A2LA)
http://www.a2la.org/dirsearchnew/
newsearch.cfm
Laboratory Accreditation Bureau (L-A-B)
http://www.l-a-b.com/content/directoryaccredited-labs
ANSI-ASQ National Accreditation Board (ACLASS)
http://www.aclasscorp.com/searchaccredited-companies.aspx
International Accreditation Service (IAS)
http://www.iasonline.org/Calibration_
Laboratories/CL.html
Perry Johnson Laboratory Accreditation, Inc.(PJLA)
http://www.pjlabs.com/search-accreditedlabs
A listing of signatory bodies outside of the U.S.
can be found on the ILAC website:
https://www.ilac.org/members_contact_
details.html
38
Temperature Monitoring Equipment
All temperature monitoring devices experience
“drift” over time that affects their accuracy.
When traceability and calibration testing
needs to be done, CDC recommends one of the
following:
• Have accuracy of your temperature
monitoring device tested. Calibration testing
should be performed every 1 to 2 years
from the last testing date or according to
the manufacturer’s suggested timeline.
Providers who receive VFC vaccines or other
vaccines purchased with public funds should
consult their immunization program
regarding the required timeframe for
calibration testing.
• Purchase a new temperature monitoring
device with a Certificate of Traceability and
Calibration Testing (also known as a Report
of Calibration).
• Contact your immunization program
for
resources on checking the accuracy of your
temperature monitoring device.
If calibration testing indicates that your
temperature monitoring device is no longer
accurate within +/-1°F (+/-.5°C), then it should be
replaced. Adjustments to correct accuracy of the
device are not recommended.
If a temperature monitoring device is dropped
or hit against the side of the storage unit, CDC
recommends that at minimum, the device be
checked for accuracy against a known calibrated
temperature monitoring device. Mishandling
a temperature monitoring device can affect its
accuracy. If there is any question about accuracy,
your device should be sent for calibration testing
or a new device should be obtained.
Some temperature monitoring devices require
batteries. If you use one of these, have a supply
of extra batteries on hand. If you change a
battery (this does not include an alarm battery) in
your device, it should undergo calibration testing
as described above.
Purchasing a replacement device may be less
expensive than calibration testing.
Types of Temperature Monitoring Devices
Continuous monitoring devices
CDC recommends using a continuous
temperature monitoring device for each storage
unit. These devices can provide an indication of
length of time a unit has been operating outside
the recommended vaccine storage temperature
(excursion) and when an excursion occurred.
Unlike a simple min/max thermometer, which
provides only information about warmest and
coldest temperatures that were reached, the
continuous monitoring device provides detailed
information on all temperatures recorded at
preset intervals. There are a variety of devices
available.
Contact your immunization program
for resources and information on acceptable
temperature monitoring devices.
Based on studies of temperature monitoring
devices conducted by NIST in 2009,1 CDC
recommends devices with the following
characteristics:
1. Digital display on outside of storage unit
to allow reading temperatures without
opening unit door
2. Detachable probe in a bottle filled with
a thermal buffer, like glycol, which more
closely reflects vaccine temperatures.
Vaccine temperatures have been found to
be more thermostable than air temperature,
which fluctuates with defrost cycles and
39
Temperature Monitoring Equipment
Attach digital display to
outside of refrigerator
Cable is not thick enough to
affect refrigerator door seal
Digital display of temperature monitoring device on outside of storage unit
How to Set up a Probe in Fluid-filled Bottle
Immersion depth
> 10 x PD
Select a glass or plastic bottle
• Minimum diameter = 4 x probe diameter (PD)
• Bottle height chosen so that:
––Immersion depth ≥ 10 x probe diameter
––Probe tip to bottom ≥ 1 to 2 cm
• Sealable lid preferred (e.g., pierceable, rubber septum cap)
Note: If manufacturer supplies a fluid-filled bottle/vial with
data logger, this may be used instead.
Bottle width
> 4 x PD
Completely fill bottle with fluid (e.g., glycol)
Probe diameter
(PD)
1-2 cm
Insert probe through center of cap
• Position probe tip to achieve depth ≥ 10 x PD
• Make sure tip doesn’t touch bottom of bottle
• Make sure entire length of probe is centered within bottle
• To keep probe from shifting, fix cable to outside of bottle
with tape or cable tie
Probe in thermal buffer such as glycol, inside unit is attached by cable to main monitor
40
Temperature Monitoring Equipment
3.
4.
5.
6.
7.
opening and closing the unit door
Alarm to alert out- of- range temperatures
Accuracy within +/-1°F (+/-.5°C)
Low battery indicator
Continuous monitoring and recording
capabilities to track and record
temperatures over time
Display of current, as well as minimum and
maximum temperatures, which indicate
the coldest and warmest temperatures
recorded since device was reset
CDC recommends having a back-up
temperature monitoring device in the event
that something happens to the primary device
or if the primary device needs to be sent to a
laboratory for calibration testing. The back-up
temperature monitoring device should have
the same set-up as the primary set-up (i.e.,
probe in buffer such as glycol). In addition, CDC
recommends that the back-up device have a
different calibration testing schedule so that your
back-up is available when the primary is sent for
testing.
Some immunization programs require VFC
providers to have a back-up thermometer.
Contact your immunization program
for
specific requirements.
Digital data loggers
CDC recommends using digital data loggers
for continuous temperature monitoring and
recording. These electronic devices may be
programmed to record temperatures at intervals
throughout the day, with frequency of reading
set by user. Digital data logger temperature
monitoring devices are capable of recording
and storing thousands of individual temperature
readings.
Digital data loggers are typically battery
operated. They are often simple to use and have
a number of beneficial features. Choose a model
that is capable of displaying current, as well as
minimum and maximum temperatures. An alarm
that rings outside the storage unit is preferable
as it is readily noticed and can be responded to
quickly.
Digital data loggers
Digital units store continuous temperature
data, which can then be downloaded into
a computer or retrieved from a website for
review and archiving. These devices may
be accompanied by special software that is
installed on a computer. Either the software or
the website may allow the user to set frequency
of temperature readings, download data from
device, and review minimums and maximums.
To review temperature history, the user must
download data from the digital data logger on a
regular basis. Even if you don’t have a computer
for downloading data, these devices are still
helpful in monitoring temperatures a minimum
of 2 times each workday, as well as providing
minimum and maximum temperatures since the
last reading.
41
Temperature Monitoring Equipment
CDC recommends that temperatures
displayed on the unit are still reviewed and
recorded a minimum of 2 times each workday,
as well as minimum and maximum temperatures
since the last reading, to determine if
temperatures are out of range.
In conclusion, the data logger should have the
following:
• Alarm for out-of-range temperatures
• Current, minimum, and maximum
temperatures
• Low battery indicator
• Accuracy of +/-1°F (+/-.5°C)
• Memory storage of at least 4,000 readings
• User programmable logging interval (or
reading rate)
Use of calibrated digital data loggers is a
best practice.
Data logger
Most data loggers contain a probe that is used
to detect temperature readings. As stated
previously, CDC recommends using probes
encased in a thermal buffer such as glycol
because they provide a more accurate reading
of actual vaccine temperature. Some data
loggers have digital displays showing current
and min/max temperatures, as well as current
room temperature. Some data loggers have an
audible alarm to alert the user to out-of-range
temperatures. Other data loggers have external
lights that alert the user (a green light indicates
temperatures have remained in range and a red
light indicates an inappropriate temperature
occurred).
If the alarm activates, take immediate
corrective action. Download and review
temperature readings and proceed as noted
in Handling Inappropriate Vaccine Storage
Conditions (Light and Temperature).
Staff should be trained and understand how to set up,
read, and analyze temperature data provided by the
data logger. Consult your immunization program
for data logger selection and training resources.
Temperature Monitoring Devices that are NOT
Recommended
CDC does NOT recommend the following
temperature monitoring devices:
• Fluid-filled biosafe liquid temperature
monitoring devices
• Bi-metal stem temperature monitoring
devices
• Food temperature monitoring devices
• Household mercury temperature monitoring
devices
• Chart recorders
• Infrared temperature monitoring devices
• Temperature monitoring devices that are not
calibrated
These devices can have significant limitations. They
can be difficult to read and most only provide
information on the temperature at the precise time
they are read. Therefore, temperature fluctuations
outside the recommended range may not be
detected.
42
Temperature Monitoring Equipment
Testing demonstrated that infrared thermometers (IR thermometers) are
not reliable or accurate for assessment of vaccine storage temperatures. 1
Do not use temperature monitoring devices that do not have a
certificate of calibration. Generally, devices obtained in hardware and
appliance stores are not calibrated instruments and are designed to
monitor temperatures for domestic food storage. These devices are
not accurate enough and can pose a significant risk of losing expensive
vaccines.
Temperature Monitoring Device Placement
Prior to storing vaccines in a unit, determine where the most reliable and
consistent temperature readings are and store your vaccines there. The
probe should be near where vaccines are being stored.
This should be in the main body of the storage unit, away from walls,
ceiling, cooling vents, doors, floor, and back of the unit.
Placement of probe
Vaccine Security
Protecting Power Supply
To prevent problems with the power supply, take the following steps:
• Plug only one storage unit into an outlet to avoid triggering a
safety switch and turning off power, and to avoid creating a fire
hazard.
• Use a safety-lock plug or an outlet cover to prevent unplugging.
• Post warning signs at plugs and on storage units alerting staff,
custodians, electricians, or other workers not to unplug units (Do
NOT unplug).
• Label fuses and circuit breakers to alert people not to turn off
power to storage units. Labels should include immediate steps to
take if power is interrupted. If your building is owned by a third
party and you do not have access to circuit breakers, work with
your building manager.
Avoid using power outlets with:
• Built-in circuit switches (they have little red reset buttons)
• Outlets that can be activated by a wall switch
• Multi-outlet power strips
These can be tripped or switched off, resulting in loss of electricity to
the storage unit.
43
Temperature Monitoring Equipment
Temperature Alarms
Alarms are a useful tool to alert staff
to potential problems. However, any
alarm is only as good as the people
responding to it. Large vaccine
losses and the need to revaccinate
have occurred despite using
alarmed, continuous monitoring
systems. Issues around untrained
Continuous monitoring temperature alarm/notification systems
staff who do not know how to read
the monitor, unexpected events, poor monitoring and response procedures, equipment failure, and
improper maintenance have all been implicated in vaccine mishandling incidents. Refer to Storage
Unit Temperature Monitoring. VFC providers or providers who receive other vaccines purchased
with public funds should contact their immunization program
for further guidance.
References
1. National Institute of Standards and Technology (NIST); Assessing the Use of Infrared
Thermometers for Vaccine Temperature Determination, http://www.nist.gov/pml/div685/
grp01/upload/IR_Test_Results.pdf
44
Temperature Monitoring Equipment
Notes:
45
Vaccine Storage and Handling Best Practices
Key Messages:
Always refer to manufacturer’s product information/package inserts
for the most up-todate storage and handling recommendations for specific vaccines and diluents.
Store frozen vaccines in freezer between -58°F and +5°F (-50°C and -15°C).
Store refrigerated vaccines between 35°F and 46°F (2°C and 8°C), with a desired average
temperature of 40°F (5°C).
Place vaccines and diluents with soonest expiration dates in front of those with later
expiration dates.
In refrigerator, do not store vaccines in deli, fruit, and vegetable drawers, or on floor.
Avoid storing vaccines on refrigerator top shelf. If top shelf must be used, place water bottles
close to vent and only store vaccines not sensitive to coldest temperatures (e.g., MMR).
Place vaccines and diluents 2 to 3 inches from walls and allow space between rows of
vaccines and diluents to promote cold air circulation. Do not place near vents or pack unit
too tightly.
Keep vaccines and diluents in original packaging with lids closed until ready for
administration.
Label and store look-alike or sound-alike vaccines (e.g., Hib and HepB), and pediatric and
adult formulations (e.g., DTaP and Tdap) of the same vaccine in different locations to lessen
risk of administration errors (Vaccine Labels for Storage Unit
).
Clearly label diluents (IAC’s Vaccines with Diluents: How to Use Them
).
Store food and beverages in separate refrigerator and storage units than where vaccines are
stored.
NEVER store vaccines and other medications or biologics in same tray or containers/bins. If
possible, store products other than vaccines in different unit.
46
Vaccine Storage and Handling Best Practices
Vaccine and Diluent Storage Temperatures
Always refer to the manufacturer’s
product information/package inserts
for
the most up-to-date storage and handling
recommendations for specific vaccines and
diluents.
Freezer Temperature
Store frozen vaccines (e.g., varicella-containing
vaccines [VAR, HZV, and MMRV]) in a freezer
between -58°F and +5°F (-50°C and -15°C)
until reconstitution and administration. These
vaccines can deteriorate rapidly after removal
from the freezer. Measles, mumps, and rubella
vaccine (MMR) can be stored in a refrigerator or
in a freezer.
Vaccine and Diluent Placement within
Storage Unit
Place vaccines and diluents with soonest
expiration dates in front of those with later
expiration dates.
Freezers
• Store vaccines away from walls, ceiling, and
vents.
• Do not store vaccines in the door. The
temperature in the door is not stable and
differs from that inside the unit.
Refrigerator Temperature
Store all other routinely recommended vaccines
in a refrigerator between 35°F and 46°F (2°C
and 8°C), with a desired average temperature of
40°F (5°C). This will allow for slight temperature
fluctuations while still maintaining the
recommended temperature range.
Diluents
Some diluents must be stored in the refrigerator.
Other diluents have an option of being stored at
room temperature (no warmer than 77°F [25°C])
or in the refrigerator.
Whenever possible, store diluent with the
corresponding refrigerated vaccine. Diluents for
Pentacel (DTaP-IPV-Hib combination vaccine)
and Menveo (meningococcal conjugate vaccine)
contain antigen. They are packaged together
with the corresponding lyophilized vaccine and
must be stored together (package inserts)
.
NEVER store diluent in the freezer.
Vaccines in freezer with frozen coolant packs
Refrigerators
• Store vaccines away from walls, floor, ceiling,
and vents.
• Do not store vaccines in deli, fruit,
and vegetable drawers, or in the door.
Temperature and air flow in these areas
may not be stable, exposing vaccines to
inappropriate storage temperatures.
• Avoid storing vaccines on top shelf. If top
shelf of refrigerator must be used, place
water bottles close to vent and only store
vaccines that are not sensitive to coldest
temperatures (e.g., MMR).
47
Vaccine Storage and Handling Best Practices
Air vents and water bottles
Water bottles on unit floor
Water bottles in unit door
Spacing
Packaging
Place vaccines and diluents in central area of unit
2 to 3 inches away from storage unit walls. Store
vaccines and diluents by type and arrange in
rows.
Keep vaccines and diluents in their
original packaging with lids closed until ready
for administration to protect them from
light. Removing vaccines and diluents from
original packaging is not recommended. This
can increase risks for storage, handling, and
administration errors.
Allow space between rows to promote cold
air circulation around vaccines and diluents.
Adequate cold air circulation helps each vaccine
and diluent maintain a consistent temperature.
Do NOT pack any vaccine storage unit too
tightly.
Do NOT store loose vials or manufacturer-filled
syringes outside of their packaging. This practice
makes managing inventory and tracking expiration
dates more difficult, increases risk of administration
errors, and exposes vaccines to light.
48
Vaccine Storage and Handling Best Practices
Store vaccines and diluents with similar packaging or names on different shelves to lessen risk
of administration errors. If you have pediatric and adult formulations of the same vaccine, label and
store them on different shelves. For example, DTaP and Tdap might be easily confused, as might Hib
and HepB.
Trays and Containers/Bins
Trays and uncovered containers/bins may be used for better organization. Each should only contain
vaccine or diluent of the same type. Always allow space between trays and containers/bins for air
circulation.
Vaccine Storage Methods and Locations in the Refrigerator
Household Combination
NO vials touching glass shelf or
directly under cooling vent = 2°C to
5°C colder.
No storage in crisper
drawers: thermally isolated +
floor level runs cold. Remove
drawers, fill space with water
bottles.
Pharmaceutical
Stand-alone Freezerless
Avoid storage on top shelf – near cooling vent. First
location to exceed max allowed temp during outages.
This is an area of
caution in some
pharmaceutical units.
1°C to 2°C colder
than main fridge
space.
Best storage practice – place vaccines in center fridge space, contained in original packaging,
inside designated storage trays positioned 2 to 3 inches from refrigerator walls.
Best and worst locations for storage can vary with different types of units. A best practice is to place vaccines in central area of
unit and keep vaccines in original packaging in trays or containers/bins 2 to 3 inches away from walls.
49
Vaccine Storage and Handling Best Practices
Labeling
Clearly identify the location
of each specific vaccine type
and diluent by attaching labels
to shelves, trays, or containers/
bins where each is stored. Label
pediatric and adult versions
of the same vaccine to avoid
confusion (Vaccine Labels for
Storage Unit).
A diluent must only be used
with the corresponding vaccine.
If diluent is stored
separately from the
corresponding vaccine, label the shelf, tray, or container/
bin where it is stored (IAC’s Vaccines with Diluents: How
to Use Them
).
HepA—Pediatric Formulation
Ages: 12 months through 18 years
Use for: Any dose in the series
Route: Intramuscular (IM)
injection
HepA—Adult Formulation
Ages: 19 years and older
Use for: Any dose in the series
Route: Intramuscular (IM)
injection
Storage of Non-Vaccine Products
Food and Beverages
Store food and beverages in a separate storage unit,
not where vaccines are stored. Storing food and beverages
in the same unit with vaccines can result in:
•
•
•
•
Frequent opening of the door
Greater risk of temperature fluctuations
Excessive light exposure
Risk of spills and contamination
Do NOT store food or beverages inside a
vaccine refrigerator or freezer.
Other Medications and Biologic Products
If possible, these products should be stored in a
different unit. If they must be stored in the same unit
as vaccines, always store them below vaccines on a
different shelf. This prevents contamination of vaccines
should other products spill, and reduces the likelihood
of medication errors. NEVER store these products in the
same tray or container/bin as vaccines.
If other medications/biologics are stored in same
unit with vaccines, store on a lower shelf.
50
Vaccine Storage and Handling Best Practices
Notes:
51
Storage Unit Temperature Monitoring
Key Messages:
Routine storage and handling plans should include protocols for reviewing and recording
storage unit temperature readings a minimum of 2 times each workday and minimum and
maximum temperatures 1 time each morning.
Use of a continuous monitoring device/digital data logger to record and store temperatures
for 24-hour monitoring at regular intervals is recommended.
The data logger should have a digital display attached to the outside of unit to allow reading
temperatures without opening door and disturbing the probe.
Download and review stored temperature data at least 1 time each week.
Maintain ongoing file of temperature data, including hard copies and downloaded data, for
3 years.
If storage temperatures are in question, contact your immunization program
and/or
vaccine manufacturer(s) per your protocol for further guidance in determining if vaccine
can be used. Be prepared to provide data from temperature logs and/or data logger (CDC’s
Temperature Excursion Checklist).
Document date and time of any mechanical malfunction or power outage.
Reviewing and Recording Temperatures
If you are a VFC provider or have other
vaccines purchased with public funds, contact
your immunization program
regarding
specific requirements for reviewing and
recording storage unit temperatures.
CDC recommends that routine vaccine
storage and handling plans include protocols
for reviewing and recording storage unit
temperature readings a minimum of 2 times each
workday. This can prevent inadvertent loss of
vaccine and the potential need for revaccination
by assuring that temperature excursions are
identified quickly and
immediate corrective
action is taken. This is also an opportunity to
visually inspect the storage unit, reorganize any
vaccines that are inadvertently misplaced, and
remove any expired vaccines.
This best practice recommendation applies
to all vaccine storage units, regardless of whether
or not there is a temperature alarm or a digital
data logger temperature monitoring device.
This assures that any temperature excursions
are recognized promptly and provides early
identification of problems with your storage unit.
CDC recommends use of a continuous
monitoring device/digital data logger to record
and store temperature information at frequent
programmable intervals for 24-hour temperature
monitoring.
52
Storage Unit Temperature Monitoring
8. Download and review stored temperature
data at least 1 time each week.
9. Maintain an ongoing file of temperature
data, including hard copies and
downloaded data, for 3 years (unless state
statutes or rules require longer retention).
As a vaccine storage unit ages, you can
track recurring problems or identify how
long problems have existed by referring to
these data.
Best practices include:
1. Post a temperature log on each storage
unit door or nearby in a readily accessible
and visible location.
2. Read temperature monitoring devices
in both refrigerator and freezer units a
minimum of 2 times each workday, at least
in the morning and before leaving at the
end of the workday.
3. Record readings in both refrigerator and
freezer units on temperature logs.
4. If alarm systems are used, temperatures
should still be reviewed and recorded a
minimum of 2 times daily.
5.
Take immediate action to correct outof range temperatures.
6. Record incident and action taken (IAC’s
Vaccine Storage Troubleshooting
Record) .
7. If a temperature reading is missed, log
entry should remain blank.
Record times of readings and initials of
person who took readings.
The Immunization Action Coalition has
developed Temperature Logs )
to support
these activities.
F°
Temperature Log for Freezer – Fahrenheit
Month/Year
DAYS 1–15
Facility Name
VFC PIN or other ID #
Page 1 of 3
Monitor temperatures closely!
Take action if temp is out of range—too warm (above 5ºF) or too cold (below -58ºF).
1.
2.
3.
4.
5.
6.
1. Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible.
Do not discard vaccines unless directed to by your state/local health department and/or the
manufacturer(s).
2. Record the out-of-range temps and the room temp in the “Action” area on the bottom of the log.
3. Notify your vaccine coordinator, or call the immunization program at your state or local health
department for guidance.
4. Document the action taken on the “Vaccine Storage Troubleshooting Record” on page 3.
Write your initials below in “Staff Initials,” and note the time in “Exact Time.”
Record temps twice each workday.
Record the min/max temps once each workday—preferably in the morning.
Put an “X” in the row that corresponds to the freezer’s temperature.
If any out-of-range temp, see instructions to the right.
After each month has ended, save each month’s log for 3 years, unless state/local
jurisdictions require a longer period.
Day of Month
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Staff Initials
am
Exact Time
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
am
pm
Min/Max Temp
(since previous reading)
Danger! Temperatures above 5ºF are too warm! Write any out-of-range temps and room temp on the lines below and call your state or local health department immediately!
action a c c e p t a b l e t e m p e r a t u r e s
The data logger’s active digital display
should be attached to the outside of unit to
allow reading temperatures without opening the
door and disturbing the probe. Set data loggers
to measure temperatures at regular intervals.
CDC recommends reviewing and recording
minimum and maximum temperature readings
at the beginning of the workday. This helps to
ensure temperature excursions are identified
quickly and corrections are made to prevent
vaccine loss.
5˚F
4˚F
3˚F
2˚F
1˚F
0˚F
-1˚F
-2˚F
-3˚F
-4˚F
-58˚F to -5˚F
Write any out-of-range
temps (above 5ºF
or below -58ºF) here.
Room Temperature
If you have a vaccine storage issue, also complete “Vaccine Storage Troubleshooting Record” found on page 3.
Adapted with appreciation from California Department of Public Health
distributed by the
Immunization Action Coalition 1573 Selby Avenue • St. Paul, MN 55104 • 651-647-9009 • www.immunize.org • www.vaccineinformation.org
Technical content reviewed by the Centers for Disease Control and Prevention
www.immunize.org/catg.d/p3038F.pdf • Item #P3038F (9/13)
Temperature Log
Any temperature reading outside the
recommended range is considered a temperature
excursion (Troubleshooting). If, at any time,
53
Storage Unit Temperature Monitoring
storage temperatures are in question, contact
your immunization program
and/or vaccine
manufacturer(s) per your protocol for further
guidance in determining if vaccine can be
used. When contacting the manufacturer or
immunization program, be prepared to provide
them with data from temperature logs and/
or data logger so they can offer you the best
guidance (CDC’s Temperature Excursion
Checklist).
Noting Equipment Failures and Room
Temperatures
Document date and time of any mechanical
malfunction or power outage (e.g., IAC’s Vaccine
Storage Troubleshooting Record) .
Take immediate action to correct these
situations (Handling Malfunctioning Vaccine
Storage Units and Power Outages).
Reviewing Temperature Recording Data
The primary vaccine coordinator should
review temperature recording data at least
1 time each week to ensure appropriate
temperature documentation. If the primary
vaccine coordinator is monitoring and recording
temperatures, the alternate (back-up) vaccine
coordinator should review data at least 1 time
each week.
Notes:
54
Troubleshooting
Key Messages:
Any temperature reading outside ranges included in manufacturers’ package inserts
considered a temperature excursion.
is
Responses from vaccine manufacturers to events are dependent on information
received. Different information about the same event will inevitably lead to different
recommendations on usability of vaccine or need to revaccinate. In addition, each event
is unique and manufacturer recommendations based on existing stability data cannot be
applied to what may appear to be similar events.
Do not allow vaccines to remain in a nonfunctioning storage unit for an extended period of
time (in general, more than 2 hours). If longer, activate Emergency Vaccine Retrieval and
Storage Plan.
If temperature monitoring device indicates temperature is outside recommended range, first
check that device is appropriately placed.
Handling Inappropriate Vaccine Storage
Conditions (Light and Temperature)
If you are a VFC provider or have other
vaccines purchased with public funds, contact
your immunization program
regarding
required actions in the event of a temperature
excursion.
Take immediate action to correct
inappropriate vaccine storage conditions. Any
temperature reading outside ranges included in
manufacturers’ package inserts
is considered
a temperature excursion. However, depending
on the vaccine, it may be total amount of time
(cumulative) out of range that affects whether
the vaccine can be used. If there is any question
that a vaccine has been exposed to inappropriate
conditions, take the following steps:
1. Notify primary or alternate (back-up)
vaccine coordinator immediately. If
not available, report problem to your
supervisor
2. At minimum, document (IAC’s Vaccine
Storage Troubleshooting Record) :
a. Date and time of event
b. Room and storage unit temperatures
(include minimum/maximum
temperatures, if available)
c. Person completing report
d. Description of event*
i. General description (i.e., what
happened)
ii. Estimated length of time vaccine
may have been affected (for
example, if your temperature
monitoring device shows that
temperature of refrigerated vaccine
rose to 48°F [9°C] for 10 minutes in
morning and 5 minutes in afternoon,
total time out of range was 15
minutes)
iii.Inventory of affected vaccines
iv.At time of event, what else was in
storage unit (e.g., water bottles in
refrigerator or frozen coolant packs
in freezer)
55
Troubleshooting
v. Prior to this event, any problems
with storage unit and/or with
affected vaccines
vi.Other relevant information
e. Action taken
i. Do NOT discard vaccines
ii. Label exposed vaccines “Do NOT Use”
iii.Store exposed vaccines under
appropriate conditions (set apart
from other vaccines)
iv.Contact your immunization
program
and/or vaccine
manufacturer(s) per your protocol
for further guidance on whether to
use affected vaccines
v. What you did to prevent a similar
problem in the future
f. Results (i.e., what happened to affected
vaccines)
You may also use the Emergency Vaccine
Retrieval and Storage Plan Worksheet to help
organize your response. Consult your agency
or immunization program
for any special
instructions or forms.
Handling Malfunctioning Vaccine Storage
Units
General Instructions
Do not allow vaccines to remain in a
nonfunctioning unit for an extended period of
time (in general, more than 2 hours). If longer
than 2 hours, activate Emergency Vaccine
Retrieval and Storage Plan.
The temperature in a refrigerator or freezer can
vary throughout the unit. In addition, several
external factors can affect the temperature in the
unit, including:
1. Seasonal weather affecting room
temperature
2. Frequency of opening and closing unit
door
3. Unit’s mechanism for cooling
Leaving a refrigerator door open can cause
the thermostat to respond to warmer room
temperatures by working harder at adjusting
cooling output to maintain correct temperature
inside the unit. This increases the possibility that
the temperature will become very cold inside the
unit and possibly freeze refrigerated vaccines.
Using an open door alarm and self-closing doors
may be helpful.
Refer to the equipment user’s guide for
instructions on handling malfunctions in the unit.
Another helpful problem-solving tool is CDC’s
Temperature Excursion Checklist.
Assessing Storage Unit Door Seals
Notify the primary or alternate (back-up) vaccine coordinator
immediately of any vaccine storage unit temperature that
is outside the recommended range.
To check that door is sealing properly:
1. With door open, place thin paper strip
*Responses from vaccine manufacturers to events depend on information received. If different information about the same
event is provided to different manufacturers, this will inevitably lead to different recommendations on usability of vaccine or
need to revaccinate. In addition, each event is unique and manufacturer recommendations based on existing stability data
cannot be applied to what may appear to be similar events.
56
Troubleshooting
2.
3.
4.
5.
against front of unit (see Illustration 1).
Close door.
Pull paper strip. If it moves easily or falls
away by itself, door may need adjustment
and/or rubber seals may need to be
replaced.
Check all the way around door to make
sure seals are tight. Pay particular
attention to corners.
If problem suspected, contact repair
technician.
if it was properly placed. Proper placement helps
the provider accurately assess actual vaccine
temperatures and take immediate corrective
action if necessary.
In addition, vaccine temperatures measured
in air can be misleading with regard to actual
vaccine temperatures. A buffered probe is the
most accurate way to measure actual vaccine
temperatures.
Checking if Device Works
It is common with some devices to see a slight
variation in temperature from one reading
to another, even when unit thermostat is set
at a particular temperature. If no change in
temperature reading occurs, the device may
be faulty and may need calibration testing or
replacement.
Checking Repeated Alarm Alerts
Illustration 1—Checking the door seal (Adapted from the
User’s Handbook for Compression Refrigerators WHO/EPI/
LOG/8415)
Temperature Monitoring Device Problems
Temperature Monitoring Device Set-up
If the temperature monitoring device
indicates that the temperature is outside the
recommended range, check that the device is
appropriately placed. It should be placed in
proximity to the vaccines. If the device is placed
near walls, floor, vent, or ceiling, or in the door, it
may indicate colder or warmer temperatures than
If temperature alarm goes off repeatedly, do NOT
disconnect alarm until you are sure it is a false
alarm. Start by conducting basic checks of unit
door, power supply, and thermostat settings. If
alarm continues to sound, transfer vaccines to
back-up unit (Emergency Vaccine Retrieval
and Storage Plan). A repair technician should
check your equipment to determine need for
repair or replacement. Check the temperature
every 30 minutes using a calibrated temperature
monitoring device until the unit is in the
recommended range and stable before returning
vaccines.
57
Troubleshooting
Notes:
58
Vaccine Inventory Management
Key Messages:
Expiration dates vary by type of vaccine or diluent and lot number. They indicate the date by
which a product should be used (package inserts)
.
Once lyophilized (freeze-dried) vaccine is mixed with diluent (liquid) and reconstituted, there
is a limited time frame in which vaccine can be used (package inserts)
.
If inadvertently administered, an expired or mishandled dose generally should not be
counted as valid and should be repeated. Contact your immunization program
and/or
vaccine manufacturer(s) for guidance on revaccination.
At least 1 time each week and each time vaccines are delivered, vaccine coordinator should
ensure that someone checks and rearranges placement of vaccines and diluents in storage
unit according to expiration dates.
If you receive multiple doses of same vaccine with same presentation (i.e., single-dose vial,
multidose vial, or manufacturer-filled syringe) from same lot with same expiration date, these
doses may be documented as one entry on stock record.
Number of vaccine doses in unit and number of doses reflected on stock records should
match.
Order smaller quantities to help prevent over-ordering and subsequent risk of expired,
wasted vaccines.
If you provide VFC vaccines or other vaccines purchased with public funds, contact your
immunization program
regarding requirements pertaining to vaccine inventory management.
Vaccine Access
Only authorized staff should have access to vaccine supplies.
Expiration Dates
Interpreting Expiration Dates
All vaccines and diluents have expiration dates. These dates vary by type of vaccine or diluent and lot
number and are printed on vials, manufacturer-filled syringes, and packages. They indicate the date
by which a product should be used (package insert)
.
When the expiration date is marked with only month and year, vaccine or diluent may be used up
to and including the last day of the month indicated. If a day is included with month and year, the
vaccine may only be used through that day.
59
Vaccine Inventory Management
Vaccine Expiration Date:
08/16/15
Note: Use through August 16, 2015.
Do NOT use on or after
August 17, 2015.
Vaccine Expiration Date:
08/15
Note: Use through August 31, 2015.
Do NOT use on or after
September 1, 2015.
Vaccine may be used up to and including the expiration date.
Exceptions to Expiration Dates on Labels (Beyond Use Date)
There are 3 instances when vaccines must be used prior to the expiration date printed on the label.
1. Reconstitution
3. Manufacturer shortened expiration date
Once a lyophilized (freeze-dried) vaccine
If vaccine has been exposed to
is mixed with a diluent (liquid) and
inappropriate storage conditions, its
reconstituted into a liquid form, there is
potency may be reduced before the
a limited time frame in which the vaccine
expiration date printed on the label.
can be used. This time frame is indicated
A manufacturer may determine that
in the manufacturer’s package insert
the vaccine can be used, but with a
. Also see Reconstitution and IAC’s
shortened expiration date. Contact
Vaccines with Diluents: How to Use
your immunization program
and/
Them
.
or the vaccine manufacturer(s) per
2. Multidose vials
your protocol for further guidance in
Most multidose vials may be used until the
determining if the vaccine can be used
expiration date printed on the vial unless
with a shortened expiration date or if it
contaminated or compromised in some
should be discarded.
way. However, some multidose vials have a
When vaccines must be used prior to the
specified time frame for use once the vial
expiration date on the label, this is referred to
is entered with a needle (package insert)
as the “beyond use date” or “BUD” noted in the
. Also see Multidose Vials.
package insert . For reconstituted vaccines,
this may be a date and/or time after which the
vaccine cannot be used. The “BUD” (date and/
or time) should be noted on the label along with
the initials of the person changing the date/time.
60
Vaccine Inventory Management
Vaccines and Diluents that Cannot Be Used Before
Expiration
If vaccine transfer is necessary so vaccine
can be used before expiration, contact your
immunization program
and/or vaccine
manufacturer(s) per your protocol for guidance
(Emergency or Off-site/Satellite Facility
Transport). Appropriate inventory management
can be helpful in reducing need for transfer and
transport of vaccines.
What to Do with Expired and Mishandled Vaccines
and Diluents
Contact your immunization program
and/
or vaccine manufacturer(s), as appropriate for
your situation, for specific policies regarding
disposition of expired or mishandled vaccines.
If inadvertently administered, the dose
generally should not be counted as valid and
should be repeated. If this occurs, contact your
immunization program
and/or vaccine
manufacturer(s) for guidance on revaccination.
Stock Rotation
Immediately unpack vaccine deliveries.
At least 1 time each week and each time
vaccines are delivered, vaccine coordinator
should ensure that someone checks and
rearranges placement of vaccines and diluents
in storage unit according to expiration dates.
Vaccines with soonest expiration dates should
be placed in front of other vaccines of same type
that have later expiration dates.
Immediately remove expired vaccines
and diluents from storage units to avoid risk of
inadvertent administration.
Vaccine Inventory Accounting
General Recommendations
Proper vaccine and diluent inventory
management includes recording quantities:
• Received
• Administered, wasted, spoiled, expired,
transferred
• Currently in stock
• To be used first
• Which need to be ordered
Vaccine Stock Records
All vaccine doses removed from unit should
be totaled by vaccine type and recorded on a
stock record. Stock records should be completed
weekly. The balance of doses remaining
in stock is indicated on stock record using
tally of doses administered, wasted, spoiled,
expired, or transferred during that week. For
lyophilized (freeze-dried) vaccines that require
reconstitution, document information for
diluents on a separate vaccine stock record.
Quantities of these vaccines and diluents should
be equal at all times. Stock records may be kept
in either computerized or written formats. One
benefit of participation in an immunization
information system (IIS)
is ability to manage
vaccine inventory electronically.
Stock records should contain the following:
• Date each vaccine and diluent delivered
• Initials of person who unpacked delivery
(this person should document delivery on
stock record)
• Condition of each vaccine and diluent
upon arrival (i.e., did vaccine arrive in good
condition at proper temperature)
• Cold chain monitor (CCM) readings if
61
Vaccine Inventory Management
•
•
•
•
•
•
•
•
included in shipping container and actions
taken if monitor was triggered (Unpacking
Deliveries)
Name of each vaccine and diluent
Name of manufacturer(s)
Vaccine presentation (i.e., single-dose
vial, multidose vial, or manufacturer-filled
syringe)
Lot number(s) (each lot should be
documented separately)
Expiration date(s) for each lot (including new
expiration dates/times based on beyond
use date [BUD] guidance in manufacturers’
product information/package insert
)
Number of doses received (or balance of
doses carried forward)
Number of doses used (i.e., administered,
wasted, compromised, expired, or
transferred – if vaccine is transferred, note
destination beside number of doses)
Balance remaining (in DOSES) after
subtracting amount used (i.e., administered,
wasted, compromised, expired, or
transferred)
If you receive multiple doses of same vaccine
with same presentations from same lot with
same expiration date, these doses may be
documented as 1 entry on stock record. Simply
indicate total number of doses received of that
particular presentation (regardless of number
of vials or syringes those doses came in). For
example, if you receive 10 single-dose vials of
same vaccine meeting above criteria, these 10
vials can be documented as single entry, noting
that 10 doses were received.
If you do not have a stock record, see Sample
Stock Record for information that should be
included. A blank Stock Record is also available.
If you are a VFC provider or have other vaccines
purchased with public funds, contact your
immunization program
for information
about stock records and inventory protocols and
procedures.
Sample Stock Record
62
Vaccine Inventory Management
Tally Sheets
These should be placed in easily accessible
locations (e.g., outside unit door) and used
to document each time doses are removed
from unit, including administered, wasted,
compromised, expired, or transferred. This can
be documented with tick marks.
Tally sheets can be used to keep stock records
updated. For example, at the end of the week,
the vaccine coordinator or designated person
should add up number of doses on tally sheet
of each vaccine used and update stock record
accordingly. The old tally sheet should then be
removed and replaced with a new one for the
following week. Store and maintain used tally
sheets in a file for future reference.
If you do not have a tally sheet, see Sample Tally
Sheet for information that should be included.
A blank Tally Sheet is also available. If you are a
VFC provider or have other vaccines purchased
with public funds, contact your immunization
program
for information about tally sheets
and inventory protocols and procedures.
Documenting Administered, Wasted,
Compromised, Expired, and Transferred Doses
Contact your immunization program
for
details about inventory accounting practices.
General Guidelines
Document every dose removed from
storage unit whether administered, wasted,
compromised, expired, or transferred. Expiration
dates should be checked a minimum of 1 time
each week and stock should be rotated to ensure
that soonest to expire is in front (Expiration
Dates and Stock Rotation). Document each time
vaccine or diluent doses expire and immediately
remove from unit. These records will help you
decide how much vaccine to order to minimize
future waste. Note each time vaccine doses
cannot be used because they have been exposed
to inappropriate storage conditions or because
vials have been damaged. Once confirmed
unusable by your immunization program or
manufacturer(s), immediately remove these
vaccines from unit. Subtract these unusable
doses from running balance on stock record to
calculate new balance of doses. Contact your
Sample Tally Sheet
63
Vaccine Inventory Management
immunization program
for instructions on
how to dispose of these doses. They may have
to be discarded, but sometimes unused vaccines
may be returned for credit.
Contact immunization program
and/or
vaccine manufacturer(s) for guidance if vaccine
transfer is required. Document transfer details
on appropriate tally sheet and stock record,
including:
• Vaccine(s)/diluent(s) transferred
• Contact name
• Telephone number on delivery note or
packing slip that accompanies transfer
This helps recipient know exactly what items are
being transferred. Copies of temperature logs
that document appropriate storage also can be
included.
Counting Stock
At least 1 time each month and before ordering,
vaccine and diluent doses should be counted.
This will ensure there are enough vaccine doses
to meet needs of the facility, and is useful for
checking accuracy of running balance of doses in
the stock record. Number of vaccine doses in unit
and number of doses reflected on stock records
should match.
When counting vaccine doses:
• Always review expiration dates.
• Immediately remove expired vaccines
and diluents. Contact your immunization
program
and/or vaccine
manufacturer(s) for specific policies
regarding disposition of expired vaccines.
If expired vaccines are VFC vaccines or
other vaccines purchased with public funds,
contact your immunization program for
instructions on returning them. If expired
vaccines cannot be returned, dispose of
them appropriately (Vaccine Disposal).
• If there is a difference between count of
doses in unit and stock record balance,
enter correct balance from your count on
a separate line in stock record below old
balance. Write a note with your signature
beside it to indicate that your count has
confirmed new balance. Use new corrected
balance for all future stock calculations. If
there are inventory discrepancies of VFC
vaccines or other vaccines purchased with
public funds, contact your immunization
program
for guidance.
• At end of every month, make a summary of
amount of each vaccine and diluent used
during that month and amount of stock still
available at end of that month.
• At end of every year, total amount of
each vaccine and diluent received and
amount used. This information is useful for
determining annual vaccine needs of facility.
Vaccine Stock Calculations and Ordering
There are three main principles for
calculating amount of vaccine needed when
placing orders:
1. Order and stock only enough vaccines to
ensure there is an adequate supply to meet
patient needs. Vaccines and presentations
ordered should be appropriate for ages
and types of patients facility serves. An
adequate supply for most facilities would
normally be enough vaccines to last 60
days, with re-ordering threshold of 30 days.
While vaccine orders usually arrive within
1-2 weeks, delays can occur. Avoid placing
last-minute or rush orders to minimize the
risk that you will run out of vaccines.
64
Vaccine Inventory Management
2. Order smaller quantities to help prevent over-ordering and subsequent risk of expired, wasted
vaccines. Over-ordering can lead to unnecessarily large volumes of vaccine being stored,
increasing risk of losing a large quantity should vaccines be compromised (e.g., mechanical
failure of the storage unit).
Notes:
65
Vaccine Deliveries
Key Messages:
Arrange for vaccine and diluent deliveries to be made only when vaccine coordinator or
alternate (back-up) coordinator is on duty.
All staff members who may be involved in deliveries should be trained to immediately notify
vaccine coordinator or alternate (back-up) coordinator when deliveries arrive and ensure that
vaccines and diluents are properly stored in a timely manner.
Immediately unpack and examine deliveries upon arrival.
After contents have been checked according to procedures, immediately store vaccines and
diluents at recommended temperatures.
Staff members who accept deliveries for facility must be aware that vaccine deliveries require
immediate attention and know their responsibility in assuring cold chain is maintained.
Standard Operating Procedures
Each facility should develop its own written
standard operating procedures (SOPs) for
handling deliveries (Routine Vaccine Storage
and Handling Plan). Without SOPs, there can
be no assurance that proper procedures will
be followed or that problems will be identified,
reported, and corrected.
receptionists and other front desk personnel)
who may be involved in deliveries must be aware
of importance of maintaining cold chain. They
should be trained to:
immediately notify coordinator or alternate
(back-up) when deliveries arrive and ensure that
vaccines and diluents are properly stored in a
timely manner.
If you provide VFC vaccines or other
vaccines purchased with public funds, contact
your immunization program
for protocols
and requirements pertaining to vaccine
deliveries.
Receiving and Unpacking Deliveries
Receiving Deliveries
Arrange for vaccine and diluent deliveries
to be made only when the vaccine coordinator
or alternate (back-up) coordinator is on duty.
Consider holidays, vacations, staff schedules,
and changes in hours of operation. All staff
members (including non-medical staff, e.g.,
All staff members who accept vaccine deliveries must be
aware of the importance of maintaining the cold chain and
the need to immediately notify the vaccine coordinator or
alternate (back-up) coordinator upon arrival.
If you need to pick up vaccines or diluents from
another facility, you must ensure that cold chain
66
Vaccine Deliveries
can be maintained.
If you have VFC vaccines or other vaccines
purchased with public funds, you must
coordinate any transfer with your immunization
program. See Vaccine Transport.
Unpacking Deliveries
Immediately unpack and examine deliveries
upon arrival.
• Examine shipping container and contents for
signs of physical damage.
• Cross-check contents with packing slip to be
sure they match.
• Check expiration dates to ensure that you
have not received any vaccines or diluents
that have already expired or will expire soon
(Expiration Dates).
• Check that lyophilized (freeze-dried)
vaccines have been shipped with correct
type and quantity of diluents. For varicellacontaining vaccines, diluents should be in a
separate compartment.
• If you suspect heat or cold damage, check:
––Vaccine cold chain monitor(s) (CCM),
if present, and contact distributor or
manufacturer for guidance. CCMs may
not be required when vaccines are
shipped directly from the manufacturer.
Note: CCMs are one-time use and should
be discarded.
––Vaccines were properly packed. There
should be an insulating barrier (such as
bubble wrap, Styrofoam pellets, or some
other barrier) between vaccines and the
refrigerated or frozen coolant packs.
Examine the shipping container and its contents for any
signs of physical damage.
• If there are any discrepancies with the
packing slip or concerns about contents,
immediately notify immunization program
and/or vaccine manufacturer(s) for
guidance.
Label vaccines “Do NOT Use” and store under appropriate
conditions (set apart from other vaccines).
Storing and Documenting Deliveries
After contents have been checked according
to procedures, immediately store vaccines and
diluents at recommended temperatures and
record each vaccine and diluent, noting all
details on Stock Record. Do NOT leave shipping
container unpacked and unattended as vaccines
and diluents inside might warm to inappropriate
67
Vaccine Deliveries
temperatures and become unusable. Staff members who accept deliveries for the facility must be
aware that vaccine deliveries require immediate attention and know their responsibility in assuring
cold chain is maintained.
Notes:
68
Vaccine Transport
Key Messages:
If at all possible, have vaccines delivered directly to an off-site/satellite facility.
If vaccines must be transported to off-site/ satellite facility, the amount transported should
be limited to only what is needed for that workday. Transport and workday should total no
more than a maximum of 8 hours.
Use a calibrated temperature monitoring device with continuous monitoring and recording
capabilities during transport.
CDC recommends transport of refrigerated or frozen vaccines using a portable refrigerator/
freezer unit.
If necessary, varicella-containing vaccines that have not been reconstituted may be
transported at refrigerated temperatures. However, you must contact the vaccine
manufacturer for guidance upon arrival at off-site/satellite facility.
When packing vaccines for transport, use a barrier layer between coolant packs and vaccines
and place a calibrated temperature monitoring device next to vaccines.
Do NOT use dry ice to transport varicella-containing vaccines.
Diluents should be transported with corresponding vaccines at storage temperatures
specified in package insert
.
In advance, refrigerate diluents stored at room temperature before transporting in same
container with refrigerated vaccines so they will not increase temperature in container.
NEVER freeze diluents, even in transport.
Read and record storage unit temperature at off-site/satellite facility a minimum of 2 times
during the workday.
If vaccines are kept in transport container, read and record temperatures hourly.
Emergency or Off-site/Satellite Facility
Transport
If you provide VFC vaccines or other
vaccines purchased with public funds, contact
your immunization program
regarding
vaccine transport, details on how to pack vaccine
and diluent, and procedures for maintaining the
cold chain.
General Recommendations
Transport involves the movement of vaccine over
a short time and distance between providers.
Vaccine manufacturers do not generally
recommend or provide guidance for transport of
vaccines and CDC discourages routine transport.
If at all possible, have vaccines delivered
directly to an off-site/satellite facility. Each
69
Vaccine Transport
transport increases risk of exposing vaccines to
inappropriate storage conditions.
If vaccines must be transported to off-site/
satellite facility, the amount transported should
be limited to only what is needed for that
workday. Transport and workday should total no
more than a maximum of 8 hours.
CDC recommends using a calibrated
temperature monitoring device with continuous
monitoring and recording capabilities during
transport.
CDC does NOT recommend using cold chain
monitors (CCMs in Unpacking Deliveries) during
transport since they do not provide adequate
data on excursions that may occur. Providers
should contact immunization program
and/
or vaccine manufacturer(s) for guidance.
The facility SOP should specify that vaccines are:
• Monitored with calibrated temperature
monitoring device
• Not placed in vehicle trunk
• Delivered directly to facility
• Promptly unpacked and placed into
appropriate storage units upon arrival
(Unpacking Deliveries)
When transporting vaccines in non-commercial vehicles use
the passenger compartment—not the trunk.
There are many variables to consider when
transporting vaccines:
•
•
•
•
Type of vaccines
Time of year and seasonal temperature
Amount of vaccines
Container, packing materials, pack out
method
• Number of times container is opened and
closed
Contact your immunization program
for
specific guidance regarding vaccine transport,
details on how to pack vaccine and diluent, and
procedures for maintaining cold chain.
General Guidance
Refrigerated vaccines
• Pack refrigerated vaccines before packing
frozen vaccines.
•
CDC recommends transport with a
portable refrigerator unit. If this type of unit
is not available, a hard-sided insulated cooler
with at least 2-inch walls may be used if it
can maintain recommended temperature
range (between 35°F and 46°F [2°C and 8°C]).
• Place a layer (at least 2 inches) of
“conditioned” coolant packs in transport
container first. Coolant packs that are frozen
must be “conditioned” by leaving them at
room temperature for 1 to 2 hours until
edges have defrosted and packs look like
they’ve been “sweating.” Frozen coolant
packs that are not “conditioned” can freeze
vaccines.
• Place an insulating barrier layer on top
of coolant packs (e.g., bubble wrap or
Styrofoam pellets).
• Next, place a calibrated temperature
monitoring device (preferably with a probe
70
Vaccine Transport
•
•
•
•
•
in a thermal buffer, e.g., glycol) on top of
barrier.
Next, stack vaccines with temperature
monitoring device on top of barrier.
Place another insulating barrier layer on top
of vaccines.
Place another layer of “conditioned” coolant
packs on top of barrier.
Always ensure there is no direct contact
between coolant packs and vaccines.
Place a final insulating barrier layer (at least 2
inches) on top of coolant packs along with a
list of vaccines in container.
Transporting Varicella-containing Vaccines
The vaccine manufacturer does not recommend
transporting varicella-containing vaccines (VAR,
HZV, MMRV).
If these vaccines must be transported (e.g.,
during an emergency):
•
CDC recommends transport in a
portable freezer unit that maintains
temperature between -58°F and +5°F
(-50°C and -15°C). Portable freezers may be
available for rent in some places.
• If not using a portable freezer, use same
packing layers as noted above.
• Coolant packs should be frozen.
If necessary, varicella-containing vaccines that
have not been reconstituted may be transported
at refrigerator temperature between 36°F and
46°F (2°C and 8°C) for up to 72 continuous hours
prior to reconstitution (package inserts
).
Follow these steps:
1. Place a calibrated temperature monitoring
device (preferably with a probe in
a thermal buffer, e.g., glycol) in the
container as close as possible to vaccines.
If transported in same container with
refrigerated vaccines, place insulating
material (e.g., bubble wrap) around
refrigerated vaccines to protect from
freezing temperatures and use rubber
bands around frozen vaccines to keep
them separate.
2. Record:
a. Time vaccines are removed from
storage unit and placed in container
b. Temperature during transport
c. Time at end of transport when vaccine
returned to main storage unit
3.
Immediately upon arrival at off-site/
satellite facility:
a. Place varicella-containing vaccines in
freezer between -58°F and +5°F (-50°C
and -15°C) and label “Do NOT Use.”
Any stand-alone freezer that reliably
maintains a temperature between -58°F
and +5°F (-50°C and -15°C) is acceptable
for storage of varicella-containing
vaccines.
b. Document time vaccines are removed
from container and placed in alternate
storage unit.
c. Note: This is considered a temperature
excursion. Do NOT use vaccine until the
vaccine manufacturer is contacted at
1-800-637-2590 for guidance.
4. Do not discard vaccines without
contacting your immunization program
and/or vaccine manufacturer(s) for
guidance.
Do NOT use dry ice, even for temporary storage
or emergency transport. Dry ice may expose
varicella-containing vaccines to temperatures
colder than -58°F (-50°C).
71
Vaccine Transport
Diluents
Diluents should be transported with their
corresponding vaccines to ensure there are
always equal amounts of vaccine and diluent for
reconstitution. Follow manufacturer guidance for
specific temperature requirements. Diluents that
contain antigen (e.g., DTaP-IPV diluent used with
Hib lyophilized vaccine) should be transported
with corresponding vaccines at refrigerator
temperature. Place an insulating barrier between
diluents and coolant packs.
Refrigerate, in advance, diluents stored at
room temperature before transporting in same
container with refrigerated vaccines so they will
not increase temperature in container.
NEVER freeze diluents, even in transport.
Multidose Vials
Only if absolutely necessary, a partially used vial
may be transported to or from an off-site/satellite
facility operated by the same provider, as long as
the cold chain is properly maintained. However,
a partially used vial may NOT be transferred to
another provider or transported across state
lines.
Monitoring Temperatures at Off-site/Satellite
Facility
CDC does not recommend keeping vaccines in
a transport container(s) unless it is a portable
refrigerator or freezer unit. If vaccines must be
kept in a transport container(s) during an offsite clinic, temperature{s) should be read and
recorded at least hourly. In addition:
• Container(s) should remain closed as much
as possible
• A calibrated temperature monitoring
device(s) (preferably with a probe in a
thermal buffer, e.g., glycol) should be placed
as close as possible to vaccines
• Only amount of vaccine needed at one time
(no more than 1 multidose vial or 10 doses)
should be removed for preparation and
administration by each vaccinator
If you have concerns about vaccines or
diluents that may have been compromised
(exposed to inappropriate conditions/
temperatures or handled improperly), label them
“Do NOT Use” and store them under appropriate
conditions (set apart from other vaccines).
Immediately contact your immunization
program
and/or vaccine manufacturer(s)
for guidance. Do NOT discard the vaccines or
diluents unless directed to by your immunization
program and/or manufacturer(s).
Immediately upon arrival at off-site/
satellite facility, store vaccines at recommended
temperature range in an on-site refrigerator
or freezer. Place a calibrated temperature
monitoring device(s) in storage unit(s) with
vaccines.
Read and record temperatures a minimum
of 2 times during the workday if the vaccines are
stored in a refrigerator and freezer.
72
Vaccine Transport
Notes:
73
Vaccine Preparation
Key Messages:
Do not open a single-dose vial until ready to use. Once the protective cap is removed the
vaccine should be used or discarded at the end of the workday.
Multidose vials can be used until the expiration date printed on the vial unless contaminated,
compromised, or there is a “beyond use date” (BUD) noted in the package insert
.
NEVER use partial doses from two or more vials to obtain a full dose of vaccine.
Once a manufacturer-filled syringe is activated (i.e., syringe cap removed or needle
attached), the vaccine should be used or discarded at the end of the workday.
Diluents are NOT interchangeable unless specified by manufacturer (e.g., diluent for MMR,
VAR, HZV, and MMRV). If vaccine must be reconstituted, use only diluent supplied by
manufacturer for that vaccine.
NEVER use a stock vial of sterile water or normal saline to reconstitute vaccines.
Always check expiration dates on both diluent and vaccines to make sure neither has expired.
Refer to manufacturer’s product information/package insert
reconstituting specific vaccines.
for instructions on
CDC recommends that providers draw up vaccines only at time of administration. If not used
by the end of the workday, vaccines should be discarded.
You should only administer vaccines that you have prepared.
Preparation for Vaccine Administration
Single-dose Vials
Single-dose vials are meant for one-time use. They do not contain a bacteriostatic (preservative)
agent. Do not open a single-dose vial
until ready to use. Once the protective
cap has been removed, the vaccine
should be used because it may not be
possible to determine if the rubber seal
has been punctured. Always check the
vial before removing the cap to assure
the correct vaccine has been selected.
Unused single-dose vials without a
protective cap should be discarded at
the end of the workday.
Single-dose vials are meant for one-time use only. Once unsealed, discard vial at end of the workday.
74
Vaccine Preparation
Multidose Vials
Diluents
Multidose vials can be entered more than once
to draw up multiple doses. They do contain a
bacteriostatic (preservative) agent. They can be
used until the expiration date printed on the vial
unless contaminated, compromised in some way,
or there is a “beyond use date” or “BUD” noted in
the package insert
. Also see Exceptions to
Expiration Dates on Labels (Beyond Use Date).
A diluent is liquid that is mixed with a lyophilized
powder or pellet to reconstitute vaccine into
liquid form for administration. Diluents vary in
volume and composition. They are specifically
designed to meet volume, pH (acid/ alkaline
balance), and chemical requirements of
their corresponding vaccine. Some diluents
contain antigen (e.g., DTaP-IPV). Diluents are
NOT interchangeable unless specified by the
manufacturer (e.g., diluent for MMR, VAR, HZV,
and MMRV). If vaccine must be reconstituted
with sterile water or saline, use only the diluent
supplied for that vaccine. NEVER use a stock vial
of sterile water or normal saline to reconstitute
vaccines. Always check expiration dates on both
diluent and vaccines to make sure neither has
expired.
NEVER use partial doses from two or more vials
to obtain a dose of vaccine.
Manufacturer-filled Syringes
Manufacturer-filled syringes are prepared
and sealed under sterile conditions by the
manufacturer. Once a manufacturer-filled syringe
is activated (i.e., syringe cap removed or needle
attached), the sterile seal is broken. The vaccine
should then be used or discarded at the end of
the workday.
NEVER administer vaccine reconstituted with
the wrong diluent. If the vaccine has already
been administered, contact your immunization
program
and/or vaccine manufacturer(s) for
guidance regarding revaccination.
For general guidance on vaccine reconstitution
see Vaccine Administration
. Manufacturers’
package inserts
also contain instructions on
reconstitution of specific vaccines.
Manufacturer-filled syringes
Reconstitution
Lyophilized (Freeze-dried) Vaccines
Lyophilized (freeze-dried) vaccines may be a
powder or pellet that must be mixed with a liquid
(diluent) in a process known as “reconstitution”
before it can be administered.
Diluent + Lyophilized Powder = Reconstituted Vaccine
75
Vaccine Preparation
Predrawing Vaccines
Influenza Clinics and Predrawing Vaccines
CDC recommends that providers draw up
vaccines only at the time of administration.
Vaccine manufacturers do not recommend
that vaccines be predrawn in advance of clinics
because no data exist on stability of vaccines
stored in syringes that have been filled by
providers.
Problems associated with this practice
• Once vaccines are inside syringes, it is
difficult to tell them apart leading to
administration errors.
• Leads to vaccine waste and increases risk of
storage under inappropriate conditions.
• Most syringes are designed for immediate
administration, not for storage. Bacterial
contamination and growth can occur in
syringes with predrawn vaccine that does
not contain bacteriostatic agents.
• Vaccine components may interact with
polymers in plastic syringes over time,
potentially reducing vaccine potency.
•
Only administer a vaccine you have
prepared and drawn up. If vaccine is drawn
up by one person and administered by a
different person, the person administering
vaccine cannot be sure about what is
in the syringe and its sterility. This is a
quality control and patient safety issue
and a best practice standard of medication
administration.
As an alternative to predrawing vaccines,
CDC recommends using manufacturer-filled
syringes for large immunization clinics.
Cautions if vaccine must be predrawn:
• If more than one vaccine type is to be
administered, separate administration
stations should be set up for each vaccine
type to prevent medication errors.
• Vaccines should NOT be drawn up in
advance of arriving at clinic site. Drawing up
doses of vaccine hours or even days before a
clinic is NOT acceptable.
• At clinic site, no more than 1 multidose vial
or 10 doses should be drawn up at one time
by each vaccinator.
• Patient flow should be monitored to avoid
drawing up unnecessary doses.
• At end of workday, any remaining vaccine
in provider predrawn syringes should be
discarded.
CDC discourages predrawing vaccines.
76
Vaccine Preparation
Notes:
77
Vaccine Disposal
Key Messages:
Contact immunization program
and/or vaccine manufacturer(s) for policies regarding
disposition of unopened vials, expired vials, unused doses, and potentially compromised
vaccine.
Open vials, activated manufacturer-filled syringes, vaccine predrawn by a provider, and
broken vials and syringes are not returnable and should be appropriately discarded.
Contact your immunization program
or state environmental agency to ensure that your
vaccine disposal procedures and any related documentation are in compliance with state
and federal regulations.
Unused vaccine and diluent doses may be
returnable under certain circumstances.
Contact the vaccine supplier, which may be the
immunization program
and/or vaccine
manufacturer(s), for specific policies regarding
the disposition of unopened vials, expired vials,
unused doses, and potentially compromised
vaccine due to inappropriate storage conditions.
Open vials, activated manufacturer-filled
syringes, vaccine predrawn by a provider, and
broken vials and syringes are not returnable and
should be appropriately discarded.
Requirements for medical waste disposal are
regulated by state environmental agencies.
Contact your immunization program
or state environmental agency to ensure that
your vaccine disposal procedures and any related
documentation are in compliance with state and
federal regulations.
State-by-State Regulated Medical Waste Resource
Locator:
http://www.hercenter.org/rmw/rmwlocator.cfm
In general, most empty vaccine vials are not
considered hazardous or pharmaceutical waste
and do not require disposal in a biomedical
waste container.
78
Resources
General Vaccine Storage and Handling
Guidelines
Warning! Do Not Unplug Freezer (Spanish)
Handle with Care Poster
Do Not Unplug Refrigerator (Spanish)
Routine Vaccine Storage and Handling Plan
Worksheet
Do Not Unplug Freezer (English)
CDC’s Temperature Excursion Checklist
NIST “Storage and Monitoring of Vaccines”
CDC Vaccine Price List
Do Not Unplug Refrigerator (English)
Do Not Unplug Freezer (Spanish)
Shipping Labels (can be printed and
reproduced)
Vaccine Labels for Storage Unit
Temperature Conversion Tables
Fahrenheit to Celsius and Celsius to
Fahrenheit Conversion
Refrigerate Upon Arrival
Freeze Upon Arrival
Open Immediately: Refrigerate Upon Receipt
Vaccine Inventory Records
Open Immediately: Freeze Upon Receipt
Sample Stock Record
Refrigerate—Do Not Freeze
Stock Record
Freeze—Do Not Refrigerate
Sample Tally Sheet
Fragile: Handle with Care
Tally Sheet
Fragile
Warning Signs (can be printed and
reproduced)
Do Not Adjust Refrigerator Controls (English)
Do Not Adjust Refrigerator Controls (Spanish)
Do Not Adjust Freezer Controls (English)
Do Not Adjust Freezer Controls (Spanish)
Perishable—Rush
Emergency Vaccine Storage and
Handling Resources
Emergency Vaccine Retrieval and Storage Plan
Worksheet
Emergency Management Internet Resources
Warning! Do Not Unplug Refrigerator (English)
Warning! Do Not Unplug Refrigerator
(Spanish)
Warning! Do Not Unplug Freezer (English)
79
Resources
Other Sources for Storage and Handling Information
Immunization Action Coalition
Vaccine Package Inserts
Immunization Action Coalition
Clinic Resources
Immunization Action Coalition
Vaccines with Diluents: How to Use Them
Immunization Action Coalition
“Ask the Experts”
State Immunization Program Websites
Manufacturer/Distributor Contact Information
80
• Rotate your vaccine stocks.
• Keep VAR, HZV, and MMRV
frozen.
• Many vaccines should be
protected from light (consult
manufacturer’s product
information).
• Keep vaccines in their original
packages.
• Take immediate action if
temperatures are out of range.
• Review and record refrigerator
and freezer temperatures 2
times each workday and
min/max at beginning of
workday.
• Keep your vaccines within the
appropriate temperature
ranges.
• Keep your refrigerator and
freezer within the appropriate
temperature ranges.
Freezer
Vaccines Between
-58°F and +5°F
(-50°C and -15°C)
(2°C and 8°C)
PROTECT YOUR VACCINE
PROTECT YOUR PATIENTS
Handle
Refrigerator
with
Vaccines Between
Care!
35°F and 46°F
Resources
Vaccine Storage Rules
81
Resources
Routine Vaccine Storage and Handling Plan Worksheet
Complete the following checklist and forms and store this information in an easily
accessible area near the vaccine storage unit. See the Vaccine Storage and
Handling Plans chapter for details.
Checklist of Resources for the Routine Vaccine Storage and Handling Plan
‰‰Up-to-date contact information
––Primary and alternate (back-up) vaccine coordinators
––Local and state health department immunization programs
––Manufacturers of vaccines in your inventory
––Refrigerator and freezer maintenance and repair companies
––Vaccine storage unit alarm company (if applicable)
––Sources for packing materials, calibrated temperature monitoring devices, and portable
refrigerator/freezer units or qualified containers
‰‰Descriptions of the roles and responsibilities of the primary and alternate (back-up) vaccine
coordinators
‰‰Policy on education and training for facility staff
‰‰Summaries of the storage requirements for each type of vaccine and diluent in your
inventory
‰‰Protocols for vaccine storage unit temperature monitoring
‰‰Protocols for vaccine storage equipment maintenance
‰‰Protocols for the correct placement of vaccines within storage units
‰‰Protocols for responding to vaccine storage and handling problems
‰‰Protocols for vaccine/diluent inventory management
‰‰Protocols for receiving and unpacking vaccine/diluent deliveries
‰‰Protocols for transporting vaccines/diluents to off-site/satellite facility(ies)
‰‰Protocols for handling vaccines/diluents prior to administration
‰‰Protocols for proper disposal of vaccines, diluents, and supplies
‰‰Samples of the forms used in your vaccination program
82
Resources
Routine Vaccine Storage and Handling Plan Worksheet
Vaccine Coordinators
Vaccine Coordinators
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Primary
Alternate (Back-up)
Resources Contact List
Resources
Contact Person
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Company Name Contact
Person Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Local Health Department
Immunization Program
State Health Department
Immunization Program
Additional Resources
Electric Power Company
Generator Repair Company
(if applicable)
Refrigerator Repair
Company
Freezer Repair Company
Temperature Alarm
Monitoring Company (if
applicable)
Security or Perimeter Alarm
Company (if applicable)
83
Resources
Routine Vaccine Storage and Handling Plan Worksheet
Emergency Resources
Company Name
Contact Person
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Packing Materials
Portable refrigerator/
freezer units
Qualified containers
Qualified containers
(alternate)
Fillers (e.g., bubble wrap,
Styrofoam pellets)
Fillers (alternate)
Coolant packs
Coolant packs (alternate)
Calibrated temperature
monitoring devices
Calibrated temperature
monitoring
devices(alternate)
84
Resources
CDC’s Temperature Excursion Checklist
1. Checklist for general power loss
‰‰Contact utility company
‰‰Determine if time to restoration is acceptable
‰‰Activate alternate generator if available
2. Checklist for presumed storage unit malfunction (DISPOSITION OF STORAGE UNIT if Unit
is too warm, too cold, too noisy, or stopped):
‰‰Check circuit breakers
‰‰Unit plugged in
‰‰Door closed
‰‰Door seal adequate
‰‰Assess location of temperature monitoring devices for temperature reading
‰‰Record all temperatures
‰‰Space between vaccines for air to circulate
‰‰Coils free of dust
‰‰Temperature adjusted gradually if not set correctly (need to re-check temperatures and
record every 30 minutes)
‰‰Unit secured and level (if unit is noisy)
‰‰Screws tightened (if unit is noisy)
‰‰Technician called
3. Disposition of vaccines (if power not restored or if temperature does not begin to recover)
‰‰Label exposed vaccines “Do NOT Use” and store under appropriate conditions (set apart
from other vaccines)
‰‰Check temperature of alternate storage unit
‰‰Vaccines moved to alternate storage unit (move refrigerated vaccines first)
‰‰Document temperature excursion action taken and results
‰‰Immunization Program contacted
‰‰Manufacturer contacted
‰‰Return vaccines determined to be usable only when storage unit is stable and resume use
‰‰Determine disposition of vaccines that are compromised:
––Vaccines provided through Vaccines for Children (VFC) Program and other vaccines
purchased with public funds prepared for return to distributor.
––Vaccines purchased with private funds should be disposed of in consultation with the
manufacturer(s) and according to state regulations for medical waste. Replacement plans
will vary.
––If insured against losses of this type, contact insurance representative.
85
Resources
Fahrenheit to Celsius and Celsius to Fahrenheit Conversion
°F
°C
°F
°C
°F
°C
°C
°F
°C
°F
-22
-21
-20
-19
-18
-17
-16
-15
-14
-13
-12
-11
-10
-9
-8
-7
-6
-5
-4
-3
-2
-1
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
-30
-29.4
-28.9
-28.3
-27.8
-27.2
-26.7
-26.1
-25.6
-25
-24.4
-23.9
-23.3
-22.8
-22.2
-21.7
-21.1
-20.6
-20
-19.4
-18.9
-18.3
-17.8
-17.2
-16.7
-16.1
-15.6
-15
-14.4
-13.9
-13.3
-12.8
-12.2
-11.7
-11.1
-10.6
-10
-9.4
-8.9
-8.3
-7.8
-7.2
-6.7
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
-6.1
-5.6
-5
-4.4
-3.9
-3.3
-2.8
-2.2
-1.7
-1.1
-0.6
0
0.6
1.1
1.7
2.2
2.8
3.3
3.9
4.4
5
5.6
6.1
6.7
7.2
7.8
8.3
8.9
9.4
10
10.6
11.1
11.7
12.2
12.8
13.3
13.9
14.4
15
15.6
16.1
16.7
17.2
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
17.8
18.3
18.9
19.4
20
20.6
21.1
21.7
22.2
22.8
23.3
23.9
24.4
25
25.6
26.1
26.7
27.2
27.8
28.3
28.9
29.4
30
30.6
31.1
31.7
32.2
32.8
33.3
33.9
34.4
35
35.6
36.1
36.7
37.2
37.8
38.3
38.9
39.4
40
-30
-29
-28
-27
-26
-25
-24
-23
-22
-21
-20
-19
-18
-17
-16
-15
-14
-13
-12
-11
-10
-9
-8
-7
-6
-5
-4
-3
-2
-1
0
1
2
3
4
5
6
7
8
9
10
11
12
-22
-20.2
-18.4
-16.6
-14.8
-13
-11.2
-9.4
-7.6
-5.8
-4
-2.2
-0.4
1.4
3.2
5
6.8
8.6
10.4
12.2
14
15.8
17.6
19.4
21.2
23
24.8
26.6
28.4
30.2
32
33.8
35.6
37.4
39.2
41
42.8
44.6
46.4
48.2
50
51.8
53.6
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
55.4
57.2
59
60.8
62.6
64.4
66.2
68
69.8
71.6
73.4
75.2
77
78.8
80.6
82.4
84.2
86
87.8
89.6
91.4
93.2
95
96.8
98.6
100.4
102.2
104
86
02/15/14
N/A
The initials of the person who unpacked and checked the vaccines/diluents upon arrival
Vaccine
Totals
Balance Carried
Forward (In Doses)
2
0
2
Physical Stock
Check (In Doses)
Difference
(“Balance” minus
Physical Stock
Check)
2
††
5
7
2
2
3
1
2
Some state or local health department immunization programs have developed their own stock records for immunization
providers. Contact program staff for information. If stock records are not available from your state or local health department
or an Immunization Information System (IIS), this stock record may be used.
†† Enter the sum of “Total Doses Received/Balance Forward” minus “Total Doses Used.”
† Includes number of doses administered, wasted, unusable, expired, or transferred.
*** SDV = Single-dose vial
MDV = Multidose vial
MFS = Manufacture-filled syringe
** G = vaccines/diluents arrived in good condition
? = condition of vaccines/diluents questionable and state and local health department
immunization program and vaccine manufacturer(s) contacted. Document details/outcome
on reverse side of stock record.
*
0
5
08/29/15
03958
1
MDV
N/A
08/23/15
Merck
2
Doses
Doses Balance
Received/ Used (Doses)
Balance
†
Forward
3
PPSV23
Expiration
Date After
Reconstitution
08/15/15
G
Manufacturer Vial Type
Lot
Expira(SDV,
Number tion Date
MDV,
MFS)
BEGINNING BALANCE FOR THE MONTH
Vaccine
or
Diluent
Name
1
LST
Person
Arrival
Receiving Condition
Shipment
**
*
Month and Year: _August
_ _ _ _ _ _2015
________________________
08/09/15
08/02/15
Date
Received
or Usage
Tallied
PPSV23
Vaccine Type: _______________________________
Instructions: At the end of each month conduct a physical check of the inventory and compare it with the recorded
balance, looking for any discrepancies. If the cause of a discrepancy cannot be determined and corrected, make a
note of this. Start a new stock record page by recording the physical count of the previous page. Use the correct
physical count for the starting balance. Use the remaining lines to record new shipments of vaccines/diluents and
weekly accounts of doses used.
Stock Record
Resources
Sample Stock Record
87
Arrival
Condition
**
Manufacturer
Vial Type
(SDV,
MDV,
MFS)
Lot
Number
BEGINNING BALANCE FOR THE MONTH
Vaccine
or Diluent
Name
The initials of the person who unpacked and checked the vaccines/diluents upon arrival
Person
Receiving
Shipment
*
Expiration
Date
Includes number of doses administered, wasted, unusable, expired, or transferred.
N/A
Doses
Used†
Balance Carried
Forward (In Doses)
Difference (“Balance”
minus Physical Stock
Check)
Physical Stock Check
(In Doses)
Doses
Received/
Balance
Forward
††
Balance
(Doses)
Some state or local health department immunization programs have developed their own stock records for immunization
providers. Contact program staff for information. If stock records are not available from your state or local health department or
an Immunization Information System (IIS), this stock record may be used.
†† Enter the sum of “Total Doses Received/Balance Forward” minus “Total Doses Used.”
†
*** SDV = Single-dose vial
MDV = Multidose vial
MFS = Manufacture-filled syringe
Vaccine
Totals
Expiration
Date After
Reconstitution
Month and Year: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
** G = vaccines/diluents arrived in good condition
? = condition of vaccines/diluents questionable and state and local health department immunization
program and vaccine manufacturer(s) contacted. Document details/outcome on reverse side of stock
record.
*
Date
Received
or Usage
Tallied
Vaccine Type: ____________________________________
Instructions: At the end of each month conduct a physical check of the inventory and compare it with the recorded balance,
looking for any discrepancies. If the cause of a discrepancy cannot be determined and corrected, make a note of this. Start a new
stock record page by recording the physical count of the previous page. Use the correct physical count for the starting balance.
Use the remaining lines to record new shipments of vaccines/diluents and weekly accounts of doses used.
Stock Record
IIII IIII II
IIII IIII II
II
I
HepB
IPV
HepA (pediatric)
PPSV23
R
R
R
R
R = Refrigerator
F = Freezer
IIII IIII II
DTaP
R
)
)
)
)
)
)
)
)
(
(
(
(
(
(
(
1
( 1 )
(
2
( 2 )
14
( 12 )
II
12
( 12 )
Total
12
Doses
Transferred
(Viable)
***
( 12 )
Doses
Unusable
9
Doses
Expired
**
( 8 ) I
Doses
Wasted
Some state or local health department immunization programs have developed their own tally sheets for immunization
providers. Contact program staff for information. If tally sheets are not available from your state or local health department
immunization program or an Immunization Information System (IIS), this tally sheet may be used.
*** Viable vaccine doses transferred to your state or local health department immunization program or another facility.
** Some non-viable doses (VFC vaccines or other vaccines purchased with public funds) may need to be returned to your state or local health
department immunization program.
*
IIII III
Doses Administered
VAR
Vaccine or Diluent Name
F
Storage
Location
(R or F)
*
August 19-23, 2015 (Week 3)
Week: __________________________________________________________
Instructions: Place a copy of this sheet on the door of the refrigerator and freezer units in which you store vaccines. Record the week (by date or
week number). Write the names of the vaccines/diluents and indicate the storage location of each vaccine/diluent in the refrigerator (R) or freezer
(F). Record a tick mark for each dose of vaccine/diluent you remove from a storage unit (i.e., for each dose that is administered, wasted, unusable,
expired, or transferred). At the end of the week, add the tick marks for each vaccine/diluent and update the appropriate stock record. Remove the
completed tally sheet from each storage unit door and store in a file for future reference. Place a new copy of the tally sheet on the storage unit door.
Tally Sheet
Resources
Sample Tally Sheet
89
Doses
Expired
**
Doses
Unusable
Doses
Transferred
(Viable)
***
Total
Some state or local health department immunization programs have developed their own tally sheets for immunization providers.
Contact program staff for information. If tally sheets are not available from your state or local health department immunization
program or an Immunization Information System (IIS), this tally sheet may be used.
*** Viable vaccine doses transferred to your state or local health department immunization program or another facility.
Some non-viable doses (VFC vaccines or other vaccines purchased with public funds) may need to be returned to your state or local health department immunization
program.
Doses
Wasted
**
Doses Administered
R = Refrigerator
F = Freezer
Vaccine or Diluent Name
*
Storage
Location
(R or F)
*
Week: __________________________________________________________
Instructions: Place a copy of this sheet on the door of the refrigerator and freezer units in which you store vaccines. Record the week (by date or week number).
Write the names of the vaccines/diluents and indicate the storage location of each vaccine/diluent in the refrigerator (R) or freezer (F). Record a tick mark for each
dose of vaccine/diluent you remove from a storage unit (i.e., for each dose that is administered, wasted, unusable, expired, or transferred). At the end of the week,
add the tick marks for each vaccine/diluent and update the appropriate stock record. Remove the completed tally sheet from each storage unit door and store in a
file for future reference. Place a new copy of the tally sheet on the storage unit door.
Tally Sheet
Resources
Do Not Adjust Refrigerator Controls (English)
Do Not Adjust Refrigerator Controls (Spanish)
91
Resources
Do Not Adjust Freezer Controls (English)
Do Not Adjust Freezer Controls (Spanish)
92
Resources
Warning! Do Not Unplug Refrigerator (English)
Warning! Do Not Unplug Refrigerator (Spanish)
93
Resources
Warning! Do Not Unplug Freezer (English)
Warning! Do Not Unplug Freezer (Spanish)
94
Resources
Do Not Unplug Refrigerator (English)
Do Not Unplug Refrigerator (Spanish)
95
Resources
Do Not Unplug Freezer (English)
Do Not Unplug Freezer (Spanish)
96
Resources
Refrigerate Upon Arrival
Freeze Upon Arrival
97
Resources
Open Immediately: Refrigerate Upon Receipt
Open Immediately: Freeze Upon Receipt
98
Resources
Refrigerate—Do Not Freeze
Freeze—Do Not Refrigerate
99
Resources
Fragile: Handle with Care
Fragile
100
Resources
Perishable—Rush
101
Resources
Emergency Vaccine Retrieval and Storage Plan Worksheet
In advance of an emergency, complete the following checklist and forms and
store this information in an easily accessible area near the vaccine storage
units. See the Vaccine Storage and Handling Plans chapter for details.
Checklist of Resources for the Emergency Vaccine Retrieval and Storage Plan
‰‰Designated primary and alternate (back-up) vaccine coordinators with emergency contact
information
‰‰Emergency staff contact list in order of contact preference
‰‰Specifications of vaccine storage unit (type, brand, model number, serial number)
‰‰Alternate vaccine storage facility(ies)
‰‰Written protocols, vehicles, and drivers for transporting vaccines to and from alternate
vaccine storage facility(ies)
‰‰Written instructions for entering your facility and vaccine storage areas in emergency if
building closed. Instructions should include building security/after-hours access procedure,
floor diagram, and locations of the following:
––Alarms (including instructions for use)
––Doors
––Flashlights
––Spare batteries
––Light switches
––Keys
––Locks
––Circuit breakers
––Packing materials
‰‰Calibrated temperature monitoring devices
‰‰Portable refrigerators and freezers
‰‰Qualified containers
‰‰Appropriate packing materials to safely transport or temporarily store vaccines
‰‰Written protocol for vaccine packing refrigerated vaccines
‰‰Written protocol for vaccine packing frozen vaccines
‰‰Written protocol for vaccine transport
‰‰Written protocol for appropriately storing vaccines at alternate storage facility
‰‰Up-to-date list of manufacturers’ telephone numbers
102
Resources
Emergency Vaccine Retrieval and Storage Plan Worksheet
Vaccine Coordinators
Vaccine Coordinators
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Primary
Alternate (Back-up)
Emergency Staff Contact List*
Name
Title
Telephone Numbers
(home, cell, pager)
E-mail Address
1.
2.
3.
4.
5.
6.
* List contacts in order of preference. Determine whether all or certain persons on the list should be contacted or if
the first person reached is sufficient. Include the primary and alternate (back-up) vaccine coordinators on the list.
Vaccine Storage Unit Specifications
Type of Unit (Refrigerator
or Freezer)
Brand
Model Number
Serial Number
1.
2.
3.
4.
5.
103
Resources
Emergency Vaccine Retrieval and Storage Plan Worksheet
Emergency Resources Contact List
Emergency Resources
Company Name Contact
Person Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Additional Staff (to move
and pack vaccine)
State Health Department
Immunization Program
Local Health Department
Immunization Program
Electric Power Company
Emergency Generator
Repair Company
(if applicable)
Emergency Generator
Fuel Source (if applicable)
Refrigerator Unit Repair
Company
Freezer Unit Repair
Company
Temperature Alarm
Monitoring Company
(if applicable)
Security or Perimeter
Alarm Company
(if applicable)
Weather Service
104
Resources
Emergency Vaccine Retrieval and Storage Plan Worksheet
Alternate Vaccine Storage Facility(ies)
Emergency Resources
Company Name/Address
Contact Person
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
1.
2.
3.
4.
Transportation to Alternate Vaccine Storage Facility(ies)*
Emergency Resources
Name/Address
Contact Person
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Refrigeration Company
Refrigeration Company
(alternate)
Private Vehicle
Private Vehicle (alternate)
105
Resources
Emergency Vaccine Retrieval and Storage Plan Worksheet
Emergency Resources
Company Name
Contact Person
Name/Title
Telephone Numbers
(home, cell, pager)
E-mail Address
Packing Materials
Portable refrigerator/
freezer units
Portable refrigerator/
freezer units (alternate)
Qualified containers
Qualified containers
(alternate)
Fillers (e.g., bubble wrap,
Styrofoam pellets)
Fillers (alternate)
Coolant packs
Coolant packs (alternate)
Calibrated temperature
monitoring devices
Calibrated temperature
monitoring devices
(alternate)
106
Resources
Emergency Management Internet Resources
Three National Oceanic and Atmospheric Administration (NOAA) websites provide up-to-date
information on U.S. weather:
http://www.nws.noaa.gov/
http://www.nhc.noaa.gov/
http://www.goes.noaa.gov/
The Federal Emergency Management Agency (FEMA) offers a wide range of information on disaster
preparedness:
http://www.fema.gov/index.shtm
The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA)
offers information concerning the storage and use of temperature-sensitive biological products that
have been involved in a temporary electrical power failure or flood conditions:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ProductSecurity/ucm147243.htm
107
Resources
Manufacturer/Distributor Contact Information
Manufacturer / Distributor
Websites
Telephone
Number/E-mail
Products
800-332-2181
Smallpox
800-533-5899
Typhoid
404-639-3670
Distributor for diphtheria
antitoxin, smallpox vaccine
Acambis
http://www.pharmamedtechbi.com/
companies/199300028
Berna
http://crucell.us.com/
Centers for Disease Control and Prevention
www.cdc.gov/ncidod/srp/drugs/drugservice.html
http://www.cdc.gov/laboratory/
drugservice/index.html
CSL Limited (Merck Distributor)
https://www.merckvaccines.com/
Emergent BioSolutions
[email protected]
800-637-2590
877-246-8472
http://www.biothrax.com/
[email protected]
GlaxoSmithKline (GSK)
https://www.contactus.gsk.
com/callback.html
http://www.gskvaccines.com/
or 1-888-825-5249
IIV
AVA
DTaP, DTaP-HepB-IPV,
DTaP-IPV, HepA, HepB,
HepA-HepB, Hib, HibMenCY, HPV2, IIV, RV1,
Tdap
Massachusetts Biological Labs
http://www.umassmed.edu/
massbiologics/
MedImmune
http://www.medimmune.com/
Merck & Co., Inc
https://www.merckvaccines.com/
800-457-4626
Td
877-633-4411
medicalinformation@
medimmune.com
LAIV
800-637-2590
HepA, HepB, Hib, HibHepB, HPV4, HZV, MMR,
MMRV, PPSV23, RV5, VAR
108
Resources
Manufacturer / Distributor
Websites
Novartis
http://www.novartisvaccines.com/us/
index.shtml
Pfizer/Wyeth
http://pfizerpro.com/
Protein Sciences
http://www.flublok.com/professionals.
html
Sanofi Pasteur
https://www.vaccineshoppe.com/
Telephone
Number/E-mail
Products
877-683-4732
Vaccineinfo.us@novartis.
com
IIV, JE, MCV4, Rabies
800-438-1985
PCV13
http://www.flublok.com/
contact.html
800-822-2463
IIV3
DT, DTaP, DTaP-IPV/Hib,
Hib, IIV, IPV, MCV4, MPSV4,
Rabies, Td, Tdap, TT,
Typhoid, YF
109